OT: COVID Science - Pfizer/Moderna vaccines >90% effective; Regeneron antibody cocktail looks very promising in phase II/III trial and more

[RU848789]

My bet since March was that Regeneron's antibody cocktail (mix of two monoclonal antibodies that target two different epitopes on the virus's spike protein) was going to be our best hope for seriously improving patient response to being infected and that seems like what we're seeing with today's additional results from the ongoing phase II/III trial in mild to moderately ill COVID patients (prior to hospitalization, when an antiviral is likely to have the biggest benefit).

Certainly can't say it's a "cure" yet, but it's looking much better than any other drug out there, so far and could be a bridge to vaccines, especially as it's also being looked at as a prophylactic to prevent infection in high risk workers/possible patients. Regeneron has applied with the FDA for an Emergency Use Authorization soon, which I think makes sense. Yeah, I know - no COVID threads, but people ought to know about this. At least leave it up for a day or so. This is really important news given that Eli Lilly announced that they were stopping their trial in hospitalized COVID patients getting their single antibody treatment along with remdesivir, due to lack of efficacy (they also have a cocktail - awaiting results on that).

https://investor.regeneron.com/news...9-outpatient-trial-prospectively-demonstrates

𝗥𝗲𝗴𝗲𝗻𝗲𝗿𝗼𝗻 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹𝘀, 𝗜𝗻𝗰. (𝗡𝗔𝗦𝗗𝗔𝗤: 𝗥𝗘𝗚𝗡) 𝘁𝗼𝗱𝗮𝘆 𝗮𝗻𝗻𝗼𝘂𝗻𝗰𝗲𝗱 𝗽𝗼𝘀𝗶𝘁𝗶𝘃𝗲, 𝗽𝗿𝗼𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲 𝗿𝗲𝘀𝘂𝗹𝘁𝘀 𝗳𝗿𝗼𝗺 𝗮𝗻 𝗼𝗻𝗴𝗼𝗶𝗻𝗴 𝗣𝗵𝗮𝘀𝗲 𝟮/𝟯 𝘀𝗲𝗮𝗺𝗹𝗲𝘀𝘀 𝘁𝗿𝗶𝗮𝗹 𝗶𝗻 𝘁𝗵𝗲 𝗖𝗢𝗩𝗜𝗗-𝟭𝟵 𝗼𝘂𝘁𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝘀𝗲𝘁𝘁𝗶𝗻𝗴 𝘀𝗵𝗼𝘄𝗶𝗻𝗴 𝗶𝘁𝘀 𝗶𝗻𝘃𝗲𝘀𝘁𝗶𝗴𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗮𝗻𝘁𝗶𝗯𝗼𝗱𝘆 𝗰𝗼𝗰𝗸𝘁𝗮𝗶𝗹, 𝗥𝗘𝗚𝗡-𝗖𝗢𝗩𝟮, 𝗺𝗲𝘁 𝘁𝗵𝗲 𝗽𝗿𝗶𝗺𝗮𝗿𝘆 𝗮𝗻𝗱 𝗸𝗲𝘆 𝘀𝗲𝗰𝗼𝗻𝗱𝗮𝗿𝘆 𝗲𝗻𝗱𝗽𝗼𝗶𝗻𝘁𝘀. 𝗥𝗘𝗚𝗡-𝗖𝗢𝗩𝟮 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁𝗹𝘆 𝗿𝗲𝗱𝘂𝗰𝗲𝗱 𝘃𝗶𝗿𝗮𝗹 𝗹𝗼𝗮𝗱 𝗮𝗻𝗱 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝘃𝗶𝘀𝗶𝘁𝘀 (𝗵𝗼𝘀𝗽𝗶𝘁𝗮𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻𝘀, 𝗲𝗺𝗲𝗿𝗴𝗲𝗻𝗰𝘆 𝗿𝗼𝗼𝗺, 𝘂𝗿𝗴𝗲𝗻𝘁 𝗰𝗮𝗿𝗲 𝘃𝗶𝘀𝗶𝘁𝘀 𝗮𝗻𝗱/𝗼𝗿 𝗽𝗵𝘆𝘀𝗶𝗰𝗶𝗮𝗻 𝗼𝗳𝗳𝗶𝗰𝗲/𝘁𝗲𝗹𝗲𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲 𝘃𝗶𝘀𝗶𝘁𝘀).

"𝗧𝗵𝗲 𝗳𝗶𝗿𝘀𝘁 𝗷𝗼𝗯 𝗼𝗳 𝗮𝗻 𝗮𝗻𝘁𝗶𝘃𝗶𝗿𝗮𝗹 𝘁𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰 𝗱𝗿𝘂𝗴 𝗶𝘀 𝘁𝗼 𝗹𝗼𝘄𝗲𝗿 𝘁𝗵𝗲 𝘃𝗶𝗿𝗮𝗹 𝗹𝗼𝗮𝗱, 𝗮𝗻𝗱 𝗼𝘂𝗿 𝗶𝗻𝗶𝘁𝗶𝗮𝗹 𝗱𝗮𝘁𝗮 𝗶𝗻 𝟮𝟳𝟱 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝘀𝘁𝗿𝗼𝗻𝗴𝗹𝘆 𝘀𝘂𝗴𝗴𝗲𝘀𝘁𝗲𝗱 𝘁𝗵𝗮𝘁 𝘁𝗵𝗲 𝗥𝗘𝗚𝗡-𝗖𝗢𝗩𝟮 𝗮𝗻𝘁𝗶𝗯𝗼𝗱𝘆 𝗰𝗼𝗰𝗸𝘁𝗮𝗶𝗹 𝗰𝗼𝘂𝗹𝗱 𝗹𝗼𝘄𝗲𝗿 𝘃𝗶𝗿𝗮𝗹 𝗹𝗼𝗮𝗱 𝗮𝗻𝗱 𝘁𝗵𝗲𝗿𝗲𝗯𝘆 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹𝗹𝘆 𝗶𝗺𝗽𝗿𝗼𝘃𝗲 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗼𝘂𝘁𝗰𝗼𝗺𝗲𝘀. 𝗧𝗼𝗱𝗮𝘆'𝘀 𝗮𝗻𝗮𝗹𝘆𝘀𝗶𝘀, 𝗶𝗻𝘃𝗼𝗹𝘃𝗶𝗻𝗴 𝗺𝗼𝗿𝗲 𝘁𝗵𝗮𝗻 𝟱𝟬𝟬 𝗮𝗱𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀, 𝗽𝗿𝗼𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲𝗹𝘆 𝗰𝗼𝗻𝗳𝗶𝗿𝗺𝘀 𝘁𝗵𝗮𝘁 𝗥𝗘𝗚𝗡-𝗖𝗢𝗩𝟮 𝗰𝗮𝗻 𝗶𝗻𝗱𝗲𝗲𝗱 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁𝗹𝘆 𝗿𝗲𝗱𝘂𝗰𝗲 𝘃𝗶𝗿𝗮𝗹 𝗹𝗼𝗮𝗱 𝗮𝗻𝗱 𝗳𝘂𝗿𝘁𝗵𝗲𝗿 𝘀𝗵𝗼𝘄𝘀 𝘁𝗵𝗮𝘁 𝘁𝗵𝗲𝘀𝗲 𝘃𝗶𝗿𝗮𝗹 𝗿𝗲𝗱𝘂𝗰𝘁𝗶𝗼𝗻𝘀 𝗮𝗿𝗲 𝗮𝘀𝘀𝗼𝗰𝗶𝗮𝘁𝗲𝗱 𝘄𝗶𝘁𝗵 𝗮 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝗱𝗲𝗰𝗿𝗲𝗮𝘀𝗲 𝗶𝗻 𝘁𝗵𝗲 𝗻𝗲𝗲𝗱 𝗳𝗼𝗿 𝗳𝘂𝗿𝘁𝗵𝗲𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗮𝘁𝘁𝗲𝗻𝘁𝗶𝗼𝗻," 𝘀𝗮𝗶𝗱 𝗚𝗲𝗼𝗿𝗴𝗲 𝗗. 𝗬𝗮𝗻𝗰𝗼𝗽𝗼𝘂𝗹𝗼𝘀, 𝗠.𝗗., 𝗣𝗵.𝗗., 𝗣𝗿𝗲𝘀𝗶𝗱𝗲𝗻𝘁 𝗮𝗻𝗱 𝗖𝗵𝗶𝗲𝗳 𝗦𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰 𝗢𝗳𝗳𝗶𝗰𝗲𝗿 𝗼𝗳 𝗥𝗲𝗴𝗲𝗻𝗲𝗿𝗼𝗻. "𝗪𝗲 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗲 𝘁𝗼 𝘀𝗲𝗲 𝘁𝗵𝗲 𝘀𝘁𝗿𝗼𝗻𝗴𝗲𝘀𝘁 𝗲𝗳𝗳𝗲𝗰𝘁𝘀 𝗶𝗻 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝘄𝗵𝗼 𝗮𝗿𝗲 𝗺𝗼𝘀𝘁 𝗮𝘁 𝗿𝗶𝘀𝗸 𝗳𝗼𝗿 𝗽𝗼𝗼𝗿 𝗼𝘂𝘁𝗰𝗼𝗺𝗲𝘀 𝗱𝘂𝗲 𝘁𝗼 𝗵𝗶𝗴𝗵 𝘃𝗶𝗿𝗮𝗹 𝗹𝗼𝗮𝗱, 𝗶𝗻𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗮𝗻𝘁𝗶𝗯𝗼𝗱𝘆 𝗶𝗺𝗺𝘂𝗻𝗲 𝗿𝗲𝘀𝗽𝗼𝗻𝘀𝗲 𝗮𝘁 𝗯𝗮𝘀𝗲𝗹𝗶𝗻𝗲, 𝗼𝗿 𝗽𝗿𝗲-𝗲𝘅𝗶𝘀𝘁𝗶𝗻𝗴 𝗿𝗶𝘀𝗸 𝗳𝗮𝗰𝘁𝗼𝗿𝘀. 𝗥𝗲𝗴𝗲𝗻𝗲𝗿𝗼𝗻 𝗵𝗮𝘀 𝘀𝗵𝗮𝗿𝗲𝗱 𝘁𝗵𝗲𝘀𝗲 𝗿𝗲𝘀𝘂𝗹𝘁𝘀 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝗨.𝗦. 𝗙𝗼𝗼𝗱 𝗮𝗻𝗱 𝗗𝗿𝘂𝗴 𝗔𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗮𝘀 𝗽𝗮𝗿𝘁 𝗼𝗳 𝗶𝘁𝘀 𝗿𝗲𝘃𝗶𝗲𝘄 𝗼𝗳 𝗼𝘂𝗿 𝗘𝗺𝗲𝗿𝗴𝗲𝗻𝗰𝘆 𝗨𝘀𝗲 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻, 𝗮𝗻𝗱 𝘄𝗲 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗲 𝘁𝗼 𝗳𝗼𝗰𝘂𝘀 𝗼𝗻 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗶𝗻𝗴 𝗼𝘂𝗿 𝗼𝗻𝗴𝗼𝗶𝗻𝗴 𝘁𝗿𝗶𝗮𝗹𝘀 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗻𝗴 𝗥𝗘𝗚𝗡-𝗖𝗢𝗩𝟮 𝗳𝗼𝗿 𝘁𝗵𝗲 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁 𝗮𝗻𝗱 𝗽𝗿𝗲𝘃𝗲𝗻𝘁𝗶𝗼𝗻 𝗼𝗳 𝗖𝗢𝗩𝗜𝗗-𝟭𝟵."

 

[WhiteBus]

I don't see this lasting as long as a #s post.

 

[fsg2]

I don't see this lasting as long as a #s post.

A little ambiguous, but I like it 😆

I also think post is good info and should stay.

 

[RUSK97]

Ridiculous that a COVID post would need to disappear if people can just behave an keep politics out of this.

 

[WhiteBus]

A little ambiguous, but I like it 😆

I also think post is good info and should stay.

As do I. It should stay until some clown brings in politics. This is purely a science thread

 

[brgRC90]

If the virus tends to mutate rendering the vaccine ineffective treatments are always going to be more important.

 

[RUBOB72]

Thanks for the update and let’s hope we are successful finding some answers.

 

[Plum Street]

Thank you for the update. I hope people are civil and this lasts

 

[Knight Shift]

I don't see this lasting as long as a #s post.

I'm offended by @RU848789 's use of the word epitopes. That's an offensive word!!!




Because I don't know what it means.

 

[WhiteBus]

I'm offended by @RU848789 's use of the word epitopes. That's an offensive word!!!




Because I don't know what it means.

Me neither. We need to look it up someday if it becomes important

 

[goru7]

My bet since March was that Regeneron's antibody cocktail (mix of two monoclonal antibodies that target two different epitopes on the virus's spike protein) was going to be our best hope for seriously improving patient response to being infected and that seems like what we're seeing with today's additional results from the ongoing phase II/III trial in mild to moderately ill COVID patients (prior to hospitalization, when an antiviral is likely to have the biggest benefit).

Certainly can't say it's a "cure" yet, but it's looking much better than any other drug out there, so far and could be a bridge to vaccines, especially as it's also being looked at as a prophylactic to prevent infection in high risk workers/possible patients. Regeneron has applied with the FDA for an Emergency Use Authorization soon, which I think makes sense. Yeah, I know - no COVID threads, but people ought to know about this. At least leave it up for a day or so. This is really important news given that Eli Lilly announced that they were stopping their trial in hospitalized COVID patients getting their single antibody treatment along with remdesivir, due to lack of efficacy (they also have a cocktail - awaiting results on that).

https://investor.regeneron.com/news...9-outpatient-trial-prospectively-demonstrates

𝗥𝗲𝗴𝗲𝗻𝗲𝗿𝗼𝗻 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹𝘀, 𝗜𝗻𝗰. (𝗡𝗔𝗦𝗗𝗔𝗤: 𝗥𝗘𝗚𝗡) 𝘁𝗼𝗱𝗮𝘆 𝗮𝗻𝗻𝗼𝘂𝗻𝗰𝗲𝗱 𝗽𝗼𝘀𝗶𝘁𝗶𝘃𝗲, 𝗽𝗿𝗼𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲 𝗿𝗲𝘀𝘂𝗹𝘁𝘀 𝗳𝗿𝗼𝗺 𝗮𝗻 𝗼𝗻𝗴𝗼𝗶𝗻𝗴 𝗣𝗵𝗮𝘀𝗲 𝟮/𝟯 𝘀𝗲𝗮𝗺𝗹𝗲𝘀𝘀 𝘁𝗿𝗶𝗮𝗹 𝗶𝗻 𝘁𝗵𝗲 𝗖𝗢𝗩𝗜𝗗-𝟭𝟵 𝗼𝘂𝘁𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝘀𝗲𝘁𝘁𝗶𝗻𝗴 𝘀𝗵𝗼𝘄𝗶𝗻𝗴 𝗶𝘁𝘀 𝗶𝗻𝘃𝗲𝘀𝘁𝗶𝗴𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗮𝗻𝘁𝗶𝗯𝗼𝗱𝘆 𝗰𝗼𝗰𝗸𝘁𝗮𝗶𝗹, 𝗥𝗘𝗚𝗡-𝗖𝗢𝗩𝟮, 𝗺𝗲𝘁 𝘁𝗵𝗲 𝗽𝗿𝗶𝗺𝗮𝗿𝘆 𝗮𝗻𝗱 𝗸𝗲𝘆 𝘀𝗲𝗰𝗼𝗻𝗱𝗮𝗿𝘆 𝗲𝗻𝗱𝗽𝗼𝗶𝗻𝘁𝘀. 𝗥𝗘𝗚𝗡-𝗖𝗢𝗩𝟮 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁𝗹𝘆 𝗿𝗲𝗱𝘂𝗰𝗲𝗱 𝘃𝗶𝗿𝗮𝗹 𝗹𝗼𝗮𝗱 𝗮𝗻𝗱 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝘃𝗶𝘀𝗶𝘁𝘀 (𝗵𝗼𝘀𝗽𝗶𝘁𝗮𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻𝘀, 𝗲𝗺𝗲𝗿𝗴𝗲𝗻𝗰𝘆 𝗿𝗼𝗼𝗺, 𝘂𝗿𝗴𝗲𝗻𝘁 𝗰𝗮𝗿𝗲 𝘃𝗶𝘀𝗶𝘁𝘀 𝗮𝗻𝗱/𝗼𝗿 𝗽𝗵𝘆𝘀𝗶𝗰𝗶𝗮𝗻 𝗼𝗳𝗳𝗶𝗰𝗲/𝘁𝗲𝗹𝗲𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲 𝘃𝗶𝘀𝗶𝘁𝘀).

"𝗧𝗵𝗲 𝗳𝗶𝗿𝘀𝘁 𝗷𝗼𝗯 𝗼𝗳 𝗮𝗻 𝗮𝗻𝘁𝗶𝘃𝗶𝗿𝗮𝗹 𝘁𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰 𝗱𝗿𝘂𝗴 𝗶𝘀 𝘁𝗼 𝗹𝗼𝘄𝗲𝗿 𝘁𝗵𝗲 𝘃𝗶𝗿𝗮𝗹 𝗹𝗼𝗮𝗱, 𝗮𝗻𝗱 𝗼𝘂𝗿 𝗶𝗻𝗶𝘁𝗶𝗮𝗹 𝗱𝗮𝘁𝗮 𝗶𝗻 𝟮𝟳𝟱 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝘀𝘁𝗿𝗼𝗻𝗴𝗹𝘆 𝘀𝘂𝗴𝗴𝗲𝘀𝘁𝗲𝗱 𝘁𝗵𝗮𝘁 𝘁𝗵𝗲 𝗥𝗘𝗚𝗡-𝗖𝗢𝗩𝟮 𝗮𝗻𝘁𝗶𝗯𝗼𝗱𝘆 𝗰𝗼𝗰𝗸𝘁𝗮𝗶𝗹 𝗰𝗼𝘂𝗹𝗱 𝗹𝗼𝘄𝗲𝗿 𝘃𝗶𝗿𝗮𝗹 𝗹𝗼𝗮𝗱 𝗮𝗻𝗱 𝘁𝗵𝗲𝗿𝗲𝗯𝘆 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹𝗹𝘆 𝗶𝗺𝗽𝗿𝗼𝘃𝗲 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗼𝘂𝘁𝗰𝗼𝗺𝗲𝘀. 𝗧𝗼𝗱𝗮𝘆'𝘀 𝗮𝗻𝗮𝗹𝘆𝘀𝗶𝘀, 𝗶𝗻𝘃𝗼𝗹𝘃𝗶𝗻𝗴 𝗺𝗼𝗿𝗲 𝘁𝗵𝗮𝗻 𝟱𝟬𝟬 𝗮𝗱𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀, 𝗽𝗿𝗼𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲𝗹𝘆 𝗰𝗼𝗻𝗳𝗶𝗿𝗺𝘀 𝘁𝗵𝗮𝘁 𝗥𝗘𝗚𝗡-𝗖𝗢𝗩𝟮 𝗰𝗮𝗻 𝗶𝗻𝗱𝗲𝗲𝗱 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁𝗹𝘆 𝗿𝗲𝗱𝘂𝗰𝗲 𝘃𝗶𝗿𝗮𝗹 𝗹𝗼𝗮𝗱 𝗮𝗻𝗱 𝗳𝘂𝗿𝘁𝗵𝗲𝗿 𝘀𝗵𝗼𝘄𝘀 𝘁𝗵𝗮𝘁 𝘁𝗵𝗲𝘀𝗲 𝘃𝗶𝗿𝗮𝗹 𝗿𝗲𝗱𝘂𝗰𝘁𝗶𝗼𝗻𝘀 𝗮𝗿𝗲 𝗮𝘀𝘀𝗼𝗰𝗶𝗮𝘁𝗲𝗱 𝘄𝗶𝘁𝗵 𝗮 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝗱𝗲𝗰𝗿𝗲𝗮𝘀𝗲 𝗶𝗻 𝘁𝗵𝗲 𝗻𝗲𝗲𝗱 𝗳𝗼𝗿 𝗳𝘂𝗿𝘁𝗵𝗲𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗮𝘁𝘁𝗲𝗻𝘁𝗶𝗼𝗻," 𝘀𝗮𝗶𝗱 𝗚𝗲𝗼𝗿𝗴𝗲 𝗗. 𝗬𝗮𝗻𝗰𝗼𝗽𝗼𝘂𝗹𝗼𝘀, 𝗠.𝗗., 𝗣𝗵.𝗗., 𝗣𝗿𝗲𝘀𝗶𝗱𝗲𝗻𝘁 𝗮𝗻𝗱 𝗖𝗵𝗶𝗲𝗳 𝗦𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰 𝗢𝗳𝗳𝗶𝗰𝗲𝗿 𝗼𝗳 𝗥𝗲𝗴𝗲𝗻𝗲𝗿𝗼𝗻. "𝗪𝗲 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗲 𝘁𝗼 𝘀𝗲𝗲 𝘁𝗵𝗲 𝘀𝘁𝗿𝗼𝗻𝗴𝗲𝘀𝘁 𝗲𝗳𝗳𝗲𝗰𝘁𝘀 𝗶𝗻 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝘄𝗵𝗼 𝗮𝗿𝗲 𝗺𝗼𝘀𝘁 𝗮𝘁 𝗿𝗶𝘀𝗸 𝗳𝗼𝗿 𝗽𝗼𝗼𝗿 𝗼𝘂𝘁𝗰𝗼𝗺𝗲𝘀 𝗱𝘂𝗲 𝘁𝗼 𝗵𝗶𝗴𝗵 𝘃𝗶𝗿𝗮𝗹 𝗹𝗼𝗮𝗱, 𝗶𝗻𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗮𝗻𝘁𝗶𝗯𝗼𝗱𝘆 𝗶𝗺𝗺𝘂𝗻𝗲 𝗿𝗲𝘀𝗽𝗼𝗻𝘀𝗲 𝗮𝘁 𝗯𝗮𝘀𝗲𝗹𝗶𝗻𝗲, 𝗼𝗿 𝗽𝗿𝗲-𝗲𝘅𝗶𝘀𝘁𝗶𝗻𝗴 𝗿𝗶𝘀𝗸 𝗳𝗮𝗰𝘁𝗼𝗿𝘀. 𝗥𝗲𝗴𝗲𝗻𝗲𝗿𝗼𝗻 𝗵𝗮𝘀 𝘀𝗵𝗮𝗿𝗲𝗱 𝘁𝗵𝗲𝘀𝗲 𝗿𝗲𝘀𝘂𝗹𝘁𝘀 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝗨.𝗦. 𝗙𝗼𝗼𝗱 𝗮𝗻𝗱 𝗗𝗿𝘂𝗴 𝗔𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗮𝘀 𝗽𝗮𝗿𝘁 𝗼𝗳 𝗶𝘁𝘀 𝗿𝗲𝘃𝗶𝗲𝘄 𝗼𝗳 𝗼𝘂𝗿 𝗘𝗺𝗲𝗿𝗴𝗲𝗻𝗰𝘆 𝗨𝘀𝗲 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻, 𝗮𝗻𝗱 𝘄𝗲 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗲 𝘁𝗼 𝗳𝗼𝗰𝘂𝘀 𝗼𝗻 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗶𝗻𝗴 𝗼𝘂𝗿 𝗼𝗻𝗴𝗼𝗶𝗻𝗴 𝘁𝗿𝗶𝗮𝗹𝘀 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗻𝗴 𝗥𝗘𝗚𝗡-𝗖𝗢𝗩𝟮 𝗳𝗼𝗿 𝘁𝗵𝗲 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁 𝗮𝗻𝗱 𝗽𝗿𝗲𝘃𝗲𝗻𝘁𝗶𝗼𝗻 𝗼𝗳 𝗖𝗢𝗩𝗜𝗗-𝟭𝟵."

As I mentioned to you in May and June , the monoclonal antibody that was going to be most effective was Leronlimab, made by the small biotech Cytodyn out of Washington State. Besides being given early EIND use by the FDA in the early stage of the pandemic and having amazing results saving severe / critical patients on life support , which led the FDA to allow the company to do 2 double blinded placebo trials , one for mild/ moderate and one for severe / critical patients . To this day, it is the only company that has run the gold standard of trials , and patients in the mild to moderate trial got better in 3 days. However, because the sample size was small 84 patients , 56 Leronlimab and 28 placebo and that by Day 14 patients in this category get better on their own , the FDA did not give EUA and instead wanted the severe / critical results. Really is a joke that Remdesiver was given Eua for mild to moderate when Leronlimab results blew them away. Now the FDA a week ago shamelessly gave it full approval , 1 day after the Solidarity trial of 11, 623 patients concluded it has absolutely no benefit in reducing mortality or hospitalization time , but Big Pharma wins out again.

Right now , Leronlimab’s severe / critical trial designed to have 390 patients and have enrolled 230, has had the Data Safety Monitoring Board, the independent group of scientists , take 2 interim looks, one for safety at 149 patients, which Leronlimab passed with flying colors, and was instructed to continue trial without any changes , and more recently an efficacy look at 195 patients , where the DSMB advised to continue the study without any changes and that they recommended another look at 293 patients and they should add to the trial a look at 42 days since 28 day mortality was the primary endpoint. The fact the DSMB recommended another look with less patients than the study design ( 293 instead of 390, implies that the statistic significance will be reached at that level and the drug will likely be approved . Most times as you have seen with all the Big Pharma drugs with Lilly, convalescent plasma, the arthritis repurposed drug and every other one going through trials, have been halted because they are not safe, or they are not effective or the recommendation is to change the primary endpoint of the trial , which is what Remdesiver did, because otherwise it would have failed its trial design. Leronlimab was told to proceed without any changes. In addition , the review of the mild to moderate trial which has been completed has shown no severe adverse events in the Leronlimab arm or attributed to the drug , further proving how safe it is. Now there are 15 sites in the US and 7 in the U.K. trying to enroll the additional 63 patients so that the DSMB can take another look , which will conclusively prove that Leronlimab is the only drug that has gone through the gold standard of trials and is the one that works. Furthermore, Leronlimab is a sub cutaneous injection that can be given as an outpatient at a doctor’s office or clinic and prevent hospitalizations. Most of the other drugs , including Trump’s Regeneron cocktail is given by IV so you need to be hospitalized.

This FDA has become political and its Big Pharma dominance is almost criminal that Leronlimab has not been given at least EUA. Cytodyn has gone to the U.K., the EU, and the Philippines , where it will likely get approved first. All the money being thrown at vaccine makers, that will be unsuccessful initially and all the money being thrown at BiG Pharma treatments , while this small company has to finish its trials when the drugs have done almost nothing and given approval. It is a damn shame as this virus is spiking out of control.

 

[Knight Shift]

As I mentioned to you in May and June , the monoclonal antibody that was going to be most effective was Leronlimab, made by the small biotech Cytodyn out of Washington State. Besides being given early EIND use by the FDA in the early stage of the pandemic and having amazing results saving severe / critical patients on life support , which led the FDA to allow the company to do 2 double blinded placebo trials , one for mild/ moderate and one for severe / critical patients . To this day, it is the only company that has run the gold standard of trials , and patients in the mild to moderate trial got better in 3 days. However, because the sample size was small 84 patients , 56 Leronlimab and 28 placebo and that by Day 14 patients in this category get better on their own , the FDA did not give EUA and instead wanted the severe / critical results. Really is a joke that Remdesiver was given Eua for mild to moderate when Leronlimab results blew them away. Now the FDA a week ago shamelessly gave it full approval , 1 day after the Solidarity trial of 11, 623 patients concluded it has absolutely no benefit in reducing mortality or hospitalization time , but Big Pharma wins out again.

Right now , Leronlimab’s severe / critical trial designed to have 390 patients and have enrolled 230, has had the Data Safety Monitoring Board, the independent group of scientists , take 2 interim looks, one for safety at 149 patients, which Leronlimab passed with flying colors, and was instructed to continue trial without any changes , and more recently an efficacy look at 195 patients , where the DSMB advised to continue the study without any changes and that they recommended another look at 293 patients and they should add to the trial a look at 42 days since 28 day mortality was the primary endpoint. The fact the DSMB recommended another look with less patients than the study design ( 293 instead of 390, implies that the statistic significance will be reached at that level and the drug will likely be approved . Most times as you have seen with all the Big Pharma drugs with Lilly, convalescent plasma, the arthritis repurposed drug and every other one going through trials, have been halted because they are not safe, or they are not effective or the recommendation is to change the primary endpoint of the trial , which is what Remdesiver did, because otherwise it would have failed its trial design. Leronlimab was told to proceed without any changes. In addition , the review of the mild to moderate trial which has been completed has shown no severe adverse events in the Leronlimab arm or attributed to the drug , further proving how safe it is. Now there are 15 sites in the US and 7 in the U.K. trying to enroll the additional 63 patients so that the DSMB can take another look , which will conclusively prove that Leronlimab is the only drug that has gone through the gold standard of trials and is the one that works. Furthermore, Leronlimab is a sub cutaneous injection that can be given as an outpatient at a doctor’s office or clinic and prevent hospitalizations. Most of the other drugs , including Trump’s Regeneron cocktail is given by IV so you need to be hospitalized.

This FDA has become political and its Big Pharma dominance is almost criminal that Leronlimab has not been given at least EUA. Cytodyn has gone to the U.K., the EU, and the Philippines , where it will likely get approved first. All the money being thrown at vaccine makers, that will be unsuccessful initially and all the money being thrown at BiG Pharma treatments , while this small company has to finish its trials when the drugs have done almost nothing and given approval. It is a damn shame as this virus is spiking out of control.

Do you have some sort of special or vested interest in Cytodyn, or are you a voice for small pharma? Do you have a pharma/science background?

I don't disagree with you, the tilted towards big Pharma has been this way for a long time. The patent system is rigged in favor of big corporations and big tech, and this trend has spanned multiple administrations regardless of party.

 

[RUBOB72]

Just get something that works that’s the bottom line. This will always be around I’m convinced of that fact.

 

[GSGS]

RU#'s and goru7, really good stuff, thanks so much for sharing.

Q for RU#'s - I saw Regenerons CEO Schleifer interviewed on TV a couple of weeks ago, after Trump received their antibody cocktail. It sounded very promising, but he indicated that it would take a while for them to ramp up production and have it available in sufficient quantities if/when it received FDA approval. Any thoughts on how many months before it will be widely available to treat all vulnerable COVID patients who may benefit by it?

 

[pmvon]

As I mentioned to you in May and June , the monoclonal antibody that was going to be most effective was Leronlimab, made by the small biotech Cytodyn out of Washington State. Besides being given early EIND use by the FDA in the early stage of the pandemic and having amazing results saving severe / critical patients on life support , which led the FDA to allow the company to do 2 double blinded placebo trials , one for mild/ moderate and one for severe / critical patients . To this day, it is the only company that has run the gold standard of trials , and patients in the mild to moderate trial got better in 3 days. However, because the sample size was small 84 patients , 56 Leronlimab and 28 placebo and that by Day 14 patients in this category get better on their own , the FDA did not give EUA and instead wanted the severe / critical results. Really is a joke that Remdesiver was given Eua for mild to moderate when Leronlimab results blew them away. Now the FDA a week ago shamelessly gave it full approval , 1 day after the Solidarity trial of 11, 623 patients concluded it has absolutely no benefit in reducing mortality or hospitalization time , but Big Pharma wins out again.

Right now , Leronlimab’s severe / critical trial designed to have 390 patients and have enrolled 230, has had the Data Safety Monitoring Board, the independent group of scientists , take 2 interim looks, one for safety at 149 patients, which Leronlimab passed with flying colors, and was instructed to continue trial without any changes , and more recently an efficacy look at 195 patients , where the DSMB advised to continue the study without any changes and that they recommended another look at 293 patients and they should add to the trial a look at 42 days since 28 day mortality was the primary endpoint. The fact the DSMB recommended another look with less patients than the study design ( 293 instead of 390, implies that the statistic significance will be reached at that level and the drug will likely be approved . Most times as you have seen with all the Big Pharma drugs with Lilly, convalescent plasma, the arthritis repurposed drug and every other one going through trials, have been halted because they are not safe, or they are not effective or the recommendation is to change the primary endpoint of the trial , which is what Remdesiver did, because otherwise it would have failed its trial design. Leronlimab was told to proceed without any changes. In addition , the review of the mild to moderate trial which has been completed has shown no severe adverse events in the Leronlimab arm or attributed to the drug , further proving how safe it is. Now there are 15 sites in the US and 7 in the U.K. trying to enroll the additional 63 patients so that the DSMB can take another look , which will conclusively prove that Leronlimab is the only drug that has gone through the gold standard of trials and is the one that works. Furthermore, Leronlimab is a sub cutaneous injection that can be given as an outpatient at a doctor’s office or clinic and prevent hospitalizations. Most of the other drugs , including Trump’s Regeneron cocktail is given by IV so you need to be hospitalized.

This FDA has become political and its Big Pharma dominance is almost criminal that Leronlimab has not been given at least EUA. Cytodyn has gone to the U.K., the EU, and the Philippines , where it will likely get approved first. All the money being thrown at vaccine makers, that will be unsuccessful initially and all the money being thrown at BiG Pharma treatments , while this small company has to finish its trials when the drugs have done almost nothing and given approval. It is a damn shame as this virus is spiking out of control.

Interesting thanks. Regeneron can only be given by IV? If so, that’s a pretty big limitation but still good news.

 

[ArminRU]

Wow, huge results. Been waiting for this one. This is an absolute game changer for at risk folks.

Can’t wait to see their trial using it as a prophylactic. The manufacturing plant better be working overtime.

• On the key clinical endpoint, treatment with REGN-COV2 reduced COVID-19 related medical visits by 57% through day 29 (2.8% combined dose groups; 6.5% placebo; p=0.024).
• Treatment with REGN-COV2 reduced COVID-19 related medical visits by 72% in patients with one or more risk factor (including being over 50 years of age; body mass index greater than 30; cardiovascular, metabolic, lung, liver or kidney disease; or immunocompromised status) (combined dose groups; nominal p = 0.0065).

 

[Knight Shift]

Wow, huge results. Been waiting for this one. This is an absolute game changer for at risk folks.

Can’t wait to see their trial using it as a prophylactic. The manufacturing plant better be working overtime.

• On the key clinical endpoint, treatment with REGN-COV2 reduced COVID-19 related medical visits by 57% through day 29 (2.8% combined dose groups; 6.5% placebo; p=0.024).
• Treatment with REGN-COV2 reduced COVID-19 related medical visits by 72% in patients with one or more risk factor (including being over 50 years of age; body mass index greater than 30; cardiovascular, metabolic, lung, liver or kidney disease; or immunocompromised status) (combined dose groups; nominal p = 0.0065).

Do you have a link for this data? Would like to take a closer look. Thanks.

 

[RUSK97]

Interesting thanks. Regeneron can only be given by IV? If so, that’s a pretty big limitation but still good news.

remdesivir is administered intravenously only - usually in under two hours per administration, unless there are infusion-related reactions. These infusions could be given outpatient, but then again, if you're getting it, you're inpatient and in a pretty severe situation anyhow.

 

[RU848789]

RU#'s and goru7, really good stuff, thanks so much for sharing.

Q for RU#'s - I saw Regenerons CEO Schleifer interviewed on TV a couple of weeks ago, after Trump received their antibody cocktail. It sounded very promising, but he indicated that it would take a while for them to ramp up production and have it available in sufficient quantities if/when it received FDA approval. Any thoughts on how many months before it will be widely available to treat all vulnerable COVID patients who may benefit by it?

Do you have a link for this data? Would like to take a closer look. Thanks.

Edit - had a math error in the post below, so I fixed it and updated the analysis (my numbers for cases was way too low).

Sorry, poker night, so just getting back on line and pleasantly surprised to see the thread still here.

GS - Regeneron doesn't have enough doses for everyone who gets infected. From what I've read they expect to have about 250-400K by the end of the year, which is enough for maybe 10% of those who get infected the next 10 weeks, if we have 60K cases/day or 4200K over the next 10 weeks (see the graphic below - could be a higher case rate). However, let's say they can make 400K by the end of the year, i.e., the high end of what I've seen/heard.

That's maybe enough, this year for 1/4 of moderately sick people with symptoms, since probably 40% will be asymptomatic (CDC estimate these days) and maybe another 20% will have mild symptoms that self-resolve, leaving maybe 40% or 1680K with moderate or worse symptoms vs. maybe 400K doses. But that's all assuming that the doses can get to the places they're needed very quickly, since the data right now show this works well before someone is hospitalized.

It might work well after hospitalization, but we simply have no data on that yet, but they are doing trials with hospitalized patients and with unexposed high risk workers, as a prophylactic (almost like a "vaccine" which might work for 3-5 months, but there's no way they'll have the doses for a prophylactic and moderately ill patients). They hope to start having 500-1000K doses per month once they and Roche (their manufacturing partner) are on line early next year, which could then be enough for 40% of those infected (if 60K/day = 1800k/month of which maybe 405 or ~720K/month need treatment) - in the US - it's also not clear how this might also be distributed in any other countries (or "giving" the technology to other countries so they can make it too).

KS - my first post has the link to their press release - the data are not published anywhere else yet, that I know of; Regeneron has been good about following up announcements with scientific papers, though, so we should see something.

 

[RU848789]

remdesivir is administered intravenously only - usually in under two hours per administration, unless there are infusion-related reactions. These infusions could be given outpatient, but then again, if you're getting it, you're inpatient and in a pretty severe situation anyhow.

Remdesivir is an antiviral only given by IV and is marginally effective (one study showed some efficacy in reducing time to recovery and a more recent study showed no efficacy at all). The Regeneron drug is also only given by IV and is a mixture of two monoclonal antibodies that are essentially "identical" to human antibodies (made via cell culture from antibodies developed using mice with "humanized" immune systems).

My first post on this technology back in mid-March actually has probably the best link to an explanation of how their cocktail is being developed (it's a very nice video/interview with the lead scientists from the company).

https://rutgers.forums.rivals.com/t...es-interventions-and-more.191275/post-4449948

Another treatment approach. My buddy (who used to be in my group at Merck and is now a VP at Regeneron!) sent me this link to an NBC piece on their elegant approach to treating and or preventing COVID-19 and they're hopeful they'll have a product in the not too distant future. It's essentially antibody therapy, where a "pseudo" coronavirus is used to elicit antibodies in mice genetically altered to mimic the human immune system and the antibodies that work best to deactivate the coronavirus are then selected and cultured in large bioreactors featuring cell lines which make enough product for the market.

The product can either be a treatment for infected patients (at higher doses) or a preventative for uninfected patients, kind of like a vaccine, except with vaccines, usually some weakened or killed virus is injected so the human body makes the antibodies to it, so that when the actual virus is encountered, the body is ready to destroy it. Since no virus is being injected (just antibodies), it should make clinical trials far simpler to run (and much easier to evaluate for safety/efficacy), although it likely would only work for several months as a preventative, which would still be great, especially for health care workers. Let's hope this approach works - it has worked for other diseases like Ebola, especially as a treatment. Other companies, obviously, are pursuing similar approaches.

https://www.nbcnews.com/…/new-york-biotech-company-working-…

 

[RU848789]

As I mentioned to you in May and June , the monoclonal antibody that was going to be most effective was Leronlimab, made by the small biotech Cytodyn out of Washington State. Besides being given early EIND use by the FDA in the early stage of the pandemic and having amazing results saving severe / critical patients on life support , which led the FDA to allow the company to do 2 double blinded placebo trials , one for mild/ moderate and one for severe / critical patients . To this day, it is the only company that has run the gold standard of trials , and patients in the mild to moderate trial got better in 3 days. However, because the sample size was small 84 patients , 56 Leronlimab and 28 placebo and that by Day 14 patients in this category get better on their own , the FDA did not give EUA and instead wanted the severe / critical results. Really is a joke that Remdesiver was given Eua for mild to moderate when Leronlimab results blew them away. Now the FDA a week ago shamelessly gave it full approval , 1 day after the Solidarity trial of 11, 623 patients concluded it has absolutely no benefit in reducing mortality or hospitalization time , but Big Pharma wins out again.

Right now , Leronlimab’s severe / critical trial designed to have 390 patients and have enrolled 230, has had the Data Safety Monitoring Board, the independent group of scientists , take 2 interim looks, one for safety at 149 patients, which Leronlimab passed with flying colors, and was instructed to continue trial without any changes , and more recently an efficacy look at 195 patients , where the DSMB advised to continue the study without any changes and that they recommended another look at 293 patients and they should add to the trial a look at 42 days since 28 day mortality was the primary endpoint. The fact the DSMB recommended another look with less patients than the study design ( 293 instead of 390, implies that the statistic significance will be reached at that level and the drug will likely be approved . Most times as you have seen with all the Big Pharma drugs with Lilly, convalescent plasma, the arthritis repurposed drug and every other one going through trials, have been halted because they are not safe, or they are not effective or the recommendation is to change the primary endpoint of the trial , which is what Remdesiver did, because otherwise it would have failed its trial design. Leronlimab was told to proceed without any changes. In addition , the review of the mild to moderate trial which has been completed has shown no severe adverse events in the Leronlimab arm or attributed to the drug , further proving how safe it is. Now there are 15 sites in the US and 7 in the U.K. trying to enroll the additional 63 patients so that the DSMB can take another look , which will conclusively prove that Leronlimab is the only drug that has gone through the gold standard of trials and is the one that works. Furthermore, Leronlimab is a sub cutaneous injection that can be given as an outpatient at a doctor’s office or clinic and prevent hospitalizations. Most of the other drugs , including Trump’s Regeneron cocktail is given by IV so you need to be hospitalized.

This FDA has become political and its Big Pharma dominance is almost criminal that Leronlimab has not been given at least EUA. Cytodyn has gone to the U.K., the EU, and the Philippines , where it will likely get approved first. All the money being thrown at vaccine makers, that will be unsuccessful initially and all the money being thrown at BiG Pharma treatments , while this small company has to finish its trials when the drugs have done almost nothing and given approval. It is a damn shame as this virus is spiking out of control.

Sorry, there's simply no way a monoclonal antibody developed for HIV, with no specific activity against the coronavirus, per se, is going to outperform a monoclonal antibody cocktail expressly designed to boost the ability of the body to neutralize the cell invasion/replication of the virus, by latching on to two different regions of the receptor binding doman of the spike protein region of the virus. No way.

Leronlimab is targeted at a human protein receptor in a patient's body (as a CCR5 antagonist), and like most other mAbs that do something like that, especially those modulating the immune response system, there is always both significant risk and potential lack of efficacy, and the drug is not targeting the virus, per se, I'm not saying it can't be modestly effective, but it's highly doubtful it will have anywhere near the efficacy of antibodies, as I've been saying for months. And the fact that they're months behind schedule vs. when they were supposed to have clinical data to share on COVID is not a good sign.

 

[RU848789]

I'm offended by @RU848789 's use of the word epitopes. That's an offensive word!!!




Because I don't know what it means.

Post below and the two papers linked in it explain what an epitope is on the virus's spike protein receptor binding domain in great detail, but basically, an epitope is simply the part of an antigen (foreign body, like a virus) that is recognized by some part of the immune system, such as antibodies, B-cells or T-cells - and monoclonal antibodies are "created" to behave just like human-generated antibodies and augment our immune system, since many people don't make enough of these antibodies.

https://en.wikipedia.org/wiki/Epitope

https://rutgers.forums.rivals.com/t...es-interventions-and-more.191275/post-4609892

 

[ArminRU]

Do you have a link for this data? Would like to take a closer look. Thanks.

Regeneron's COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention | Regeneron Pharmaceuticals Inc.

TARRYTOWN, N.Y. , Oct. 28, 2020 /PRNewswire/ -- Today's data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits Regeneron has shared these results with the U.S.

investor.regeneron.com

 

[Knight Shift]

Regeneron's COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention | Regeneron Pharmaceuticals Inc.

TARRYTOWN, N.Y. , Oct. 28, 2020 /PRNewswire/ -- Today's data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits Regeneron has shared these results with the U.S.

investor.regeneron.com

I'm curious about the bolded (by me) statement:

Clinical results in the overall population (n=799):

• On the key clinical endpoint, treatment with REGN-COV2 reduced COVID-19 related medical visits by 57% through day 29 (2.8% combined dose groups; 6.5% placebo; p=0.024).
• Treatment with REGN-COV2 reduced COVID-19 related medical visits by 72% in patients with one or more risk factor (including being over 50 years of age; body mass index greater than 30; cardiovascular, metabolic, lung, liver or kidney disease; or immunocompromised status) (combined dose groups; nominal p = 0.0065).

There was no planned formal statistical analysis of symptom alleviation in this analysis; descriptive analyses did not reveal robust associations with viral load, serology status or treatment.

 

[Yeah Baby]

Good stuff. This will help drive down the total number of deaths as we go forward. We already have seen a significant improvement by not putting everyone on ventilators and by keeping the elderly out of harms way. Those mistakes were made globally. Therapeutics are also helping already and will continue to improve. The use of Vaccines is a longer term mitigation to keep the numbers down. But the Therapeutics will save more lives in the short and midterm.

 

[hrdcorhays]

@RU848789 - do you do any kind of email list for COVID discussion? I somewhat miss the COVID thread and found your posts helpful. Medical journals are far beyond what I desire to read but I like the way you sum things up. Twitter's algorithm hasn't been as helpful for me finding good info of late, or maybe I'm just drowning those voices out.

I don't have premium so I don't believe I can send a DM to you, but if such an email list exists I'd like to be included. chayesru @ gmail dot com.

 

[gregkoko]

@RU848789 - do you do any kind of email list for COVID discussion? I somewhat miss the COVID thread and found your posts helpful. Medical journals are far beyond what I desire to read but I like the way you sum things up. Twitter's algorithm hasn't been as helpful for me finding good info of late, or maybe I'm just drowning those voices out.

I don't have premium so I don't believe I can send a DM to you, but if such an email list exists I'd like to be included. chayesru @ gmail dot com.

Ditto gregkoko at gmail @RU848789

 

[RU848789]

@RU848789 - do you do any kind of email list for COVID discussion? I somewhat miss the COVID thread and found your posts helpful. Medical journals are far beyond what I desire to read but I like the way you sum things up. Twitter's algorithm hasn't been as helpful for me finding good info of late, or maybe I'm just drowning those voices out.

I don't have premium so I don't believe I can send a DM to you, but if such an email list exists I'd like to be included. chayesru @ gmail dot com.

Ditto gregkoko at gmail @RU848789

Thanks. I don't do emails for COVID, like I've done for weather for ~20 years, but I do post close to 100% of what I used to post here on Facebook, but there's a bit of politics in there too, since, it's my Facebook, of course (my FB COVID posts are probably 80% pure science and 20% with a science/politics mix). My FB is public, so if you know who I am you can read w/o friending (I don't mind friending, just saying it's not necessary). I can send the name to anyone who IM's me or gives me an email, like greg.

For folks who want to see just COVID-science discussions, with zero tolerance for politics, I post at the weather board linked below, along with a decent number of other folks (including some scientists - it's a weather board, so it's naturally a little "geeky"), although it's not nearly as active as the old COVID threads on this board used to be (but also far less cantankerous). I assume it's ok for me to post this here since I can't imagine it "hurting" this board at all.

https://www.33andrain.com/topic/194...0k-dead/page/100/?tab=comments#comment-212588

 

[goru7]

Sorry, there's simply no way a monoclonal antibody developed for HIV, with no specific activity against the coronavirus, per se, is going to outperform a monoclonal antibody cocktail expressly designed to boost the ability of the body to neutralize the cell invasion/replication of the virus, by latching on to two different regions of the receptor binding doman of the spike protein region of the virus. No way.

Leronlimab is targeted at a human protein receptor in a patient's body (as a CCR5 antagonist), and like most other mAbs that do something like that, especially those modulating the immune response system, there is always both significant risk and potential lack of efficacy, and the drug is not targeting the virus, per se, I'm not saying it can't be modestly effective, but it's highly doubtful it will have anywhere near the efficacy of antibodies, as I've been saying for months. And the fact that they're months behind schedule vs. when they were supposed to have clinical data to share on COVID is not a good sign.

Disagree. Leronlimab reduces the viral load , even though it is not an antiviral, stops the cytokines storm , and brigs the immune system in to homo stasis, so it can fight off the virus naturally. No other drug does all 3. Also Regeneron numbers had a p value of the critical endpointof reducing hospital visits of 0.024, which is not statistically significant as you know it has to be 0.005 or lower . So not that better than placebo. At least Regeneron is the only other trial out there with any success, since all others except Leronlimab have failed. Regeneron is also not going to be handy for severe to critical patients but used early on. Multiple therapeutics will be needed to fight Covid and Regeneron ‘s cocktail and Leronlimab should both be approved for use.

 

[goru7]

Sorry, there's simply no way a monoclonal antibody developed for HIV, with no specific activity against the coronavirus, per se, is going to outperform a monoclonal antibody cocktail expressly designed to boost the ability of the body to neutralize the cell invasion/replication of the virus, by latching on to two different regions of the receptor binding doman of the spike protein region of the virus. No way.

Leronlimab is targeted at a human protein receptor in a patient's body (as a CCR5 antagonist), and like most other mAbs that do something like that, especially those modulating the immune response system, there is always both significant risk and potential lack of efficacy, and the drug is not targeting the virus, per se, I'm not saying it can't be modestly effective, but it's highly doubtful it will have anywhere near the efficacy of antibodies, as I've been saying for months. And the fact that they're months behind schedule vs. when they were supposed to have clinical data to share on COVID is not a good sign.

The mechanism of action is that Leronlimab blocks the CCR5 receptor and prevents the virus from replicating and causing the storm . It has worked on mild to moderate patients and is working on severe / critical patients. If the CEO did not make missteps along the way, the results would be completed by now. But because Leronlimab has indications to treat AIDS, triple breast cancer, Nash, Gvhd, and other indications, The FDA and its former Gilead employees have not made it easy to get approval as it will be a huge competitor for many indications. Once approval happens whether it t be in the USA or in the U.K. or Eu , the other approvals will follow. It will be approved for AIDS in 6-9 months and likely sooner in the U.K. and Canada

 

[RUBOB72]

The mechanism of action is that Leronlimab blocks the CCR5 receptor and prevents the virus from replicating and causing the storm . It has worked on mild to moderate patients and is working on severe / critical patients. If the CEO did not make missteps along the way, the results would be completed by now. But because Leronlimab has indications to treat AIDS, triple breast cancer, Nash, Gvhd, and other indications, The FDA and its former Gilead employees have not made it easy to get approval as it will be a huge competitor for many indications. Once approval happens whether it t be in the USA or in the U.K. or Eu , the other approvals will follow. It will be approved for AIDS in 6-9 months and likely sooner in the U.K. and Canada

Don’t care to regurgitate the same dialogue we had back in the late spring. If they are still blocking these possible approvals then those individuals must be dealt with.

 

[Knight Shift]

Disagree. Leronlimab reduces the viral load , even though it is not an antiviral, stops the cytokines storm , and brigs the immune system in to homo stasis, so it can fight off the virus naturally. No other drug does all 3. Also Regeneron numbers had a p value of the critical endpointof reducing hospital visits of 0.024, which is not statistically significant as you know it has to be 0.005 or lower . So not that better than placebo. At least Regeneron is the only other trial out there with any success, since all others except Leronlimab have failed. Regeneron is also not going to be handy for severe to critical patients but used early on. Multiple therapeutics will be needed to fight Covid and Regeneron ‘s cocktail and Leronlimab should both be approved for use.

Maybe it is social media noise, but are there problems with the CEO and management of Cytodyn. Saw a few things about cashing out on options and giving himself a huge raise to the tune of $10 million (I think). Not trying to knock Cytodyn, but many startups can have promising therapies but are unstable entities.

 

[ArminRU]

The other good thing about these results is that they found out that they probably can cut the dose in half. All of a sudden they can treat twice as many people.

The key is getting this treatment early on. Can’t wait for the hospital. If you test positive and are high risk, they should give you this the same day.

 

[RU848789]

Disagree. Leronlimab reduces the viral load , even though it is not an antiviral, stops the cytokines storm , and brigs the immune system in to homo stasis, so it can fight off the virus naturally. No other drug does all 3. Also Regeneron numbers had a p value of the critical endpointof reducing hospital visits of 0.024, which is not statistically significant as you know it has to be 0.005 or lower . So not that better than placebo. At least Regeneron is the only other trial out there with any success, since all others except Leronlimab have failed. Regeneron is also not going to be handy for severe to critical patients but used early on. Multiple therapeutics will be needed to fight Covid and Regeneron ‘s cocktail and Leronlimab should both be approved for use.

Statistical significance is generally assumed for p-values of <0.05, not <0.005, so you're simply wrong on this, meaning Regeneron's data are statistically significant for reducing medical visits and reducing viral loads vs. placebo, as per the excerpt below. My post linked below has a whole write-up of statistical significance and p-values, including links to the primary research on what p-values mean and how 0.05 was arrived at.

And we've simply yet to see any clinical data of significance for leronlimab and COVID, because it doesn't exist yet. I hope it's beneficial, but I'm not particularly optimistic - we should know their phase IIb/III results (390 patients; they did just get the go-ahead to complete the trial in severe/critical patients at the interim analysis after 50% of the patients had been enrolled - this was just a safety check point though, not efficacy) by the end of the year, although many are bearish on leronlimab, including Seeking Alpha.

https://seekingalpha.com/news/36235...-for-covidminus-19-passes-first-safety-review

https://rutgers.forums.rivals.com/t...es-interventions-and-more.198855/post-4638962

Virologic results (n=524, prospectively confirming previous 275-patient analysis):

• On the primary endpoint, the average daily change in viral load through day 7 (mean time-weighted average change from baseline) in patients with high viral load (defined as greater than107 copies/mL) was a 0.68 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p<0.0001). There was a 1.08 log greater reduction with REGN-COV2 treatment by day 5, which corresponds to REGN-COV2 patients having, on average, a greater than 10-fold reduction in viral load, compared to placebo.
• In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p=0.0003).
• As in the earlier analysis, patients with higher viral load at baseline and/or no detectable antibodies at baseline (suggesting their bodies had not yet mounted an effective immune response), derived greater benefit from REGN-COV2 therapy.

Clinical results in the overall population (n=799):

• On the key clinical endpoint, treatment with REGN-COV2 reduced COVID-19 related medical visits by 57% through day 29 (2.8% combined dose groups; 6.5% placebo; p=0.024).
• Treatment with REGN-COV2 reduced COVID-19 related medical visits by 72% in patients with one or more risk factor (including being over 50 years of age; body mass index greater than 30; cardiovascular, metabolic, lung, liver or kidney disease; or immunocompromised status) (combined dose groups; nominal p = 0.0065).

 

[RU Cheese]

I posted on the market thread asking where the CYDY guy was. Good to see he's back.

Also interesting to see that the promises of "patients are enrolled and drug will be approved in two weeks" that we heard quite literally in multiple threads back in June hasn't come to fruition. But now, instead of a wierd CEO, being months behind schedule, and the fact that mexhanistically there is zero logic why anti-CC5 would directly impact viral load, it's simply due to big pharma buying their way to the top. Oh, and FDA shadiness (despite no differences in EMA, MHRA, etc.). Got it.

 

[goru7]

Maybe it is social media noise, but are there problems with the CEO and management of Cytodyn. Saw a few things about cashing out on options and giving himself a huge raise to the tune of $10 million (I think). Not trying to knock Cytodyn, but many startups can have promising therapies but are unstable entities.

CEO has had his past problems and shady might characterize it but nothing recent in last few years. He bought more stock than he ever sold and lots of top doctors being brought into Scientific Board from multiple areas , HIV , Nash , Cancer, etc. He has not diluted the shares extensively. He could have hooked up with Gilead but declined . Gilead choose Immu instead for its one use about 2 months ago. I guess he believes they have the best drug that can compete with all the others. Clearly , not your typical CEO , that needed to hire more PR people , which they have finally done. They had a hard time enrolling the severe/ critical trial when the FDA approved Remdesiver as the standard of care and you were asking really Ill patients if they wanted an approved standard of care drug versus an unapproved drug with a 2:1 Leronlimab to placebo with a chance to get placebo. Unlike all of these other companies getting government money and failing , Cytodyn has not been given any government money yet. Remdesiver does hardly anything for Covid unfortunately. They have to get the other 63 enrolled quick and now have to wait 42 days after the 293 patient is injected to have the DSMB take another look.

 

[goru7]

CEO has had his past problems and shady might characterize it but nothing recent in last few years. He bought more stock than he ever sold and lots of top doctors being brought into Scientific Board from multiple areas , HIV , Nash , Cancer, etc. He has not diluted the shares extensively. He could have hooked up with Gilead but declined . Gilead choose Immu instead for its one use about 2 months ago. I guess he believes they have the best drug that can compete with all the others. Clearly , not your typical CEO , that needed to hire more PR people , which they have finally done. They had a hard time enrolling the severe/ critical trial when the FDA approved Remdesiver as the standard of care and you were asking really Ill patients if they wanted an approved standard of care drug versus an unapproved drug with a 2:1 Leronlimab to placebo with a chance to get placebo. Unlike all of these other companies getting government money and failing , Cytodyn has not been given any government money yet. Remdesiver does hardly anything for Covid unfortunately. They have to get the other 63 enrolled quick and now have to wait 42 days after the 293 patient is injected to have the DSMB take another look.

 

[letitrip2]

Statistical significance is generally assumed for p-values of <0.05, not <0.005, so you're simply wrong on this, meaning Regeneron's data are statistically significant for reducing medical visits and reducing viral loads vs. placebo, as per the excerpt below. My post linked below has a whole write-up of statistical significance and p-values, including links to the primary research on what p-values mean and how 0.05 was arrived at.

And we've simply yet to see any clinical data of significance for leronlimab and COVID, because it doesn't exist yet. I hope it's beneficial, but I'm not particularly optimistic - we should know their phase IIb/III results (390 patients; they did just get the go-ahead to complete the trial in severe/critical patients at the interim analysis after 50% of the patients had been enrolled - this was just a safety check point though, not efficacy) by the end of the year, although many are bearish on leronlimab, including Seeking Alpha.

https://seekingalpha.com/news/36235...-for-covidminus-19-passes-first-safety-review

https://rutgers.forums.rivals.com/t...es-interventions-and-more.198855/post-4638962

Virologic results (n=524, prospectively confirming previous 275-patient analysis):

• On the primary endpoint, the average daily change in viral load through day 7 (mean time-weighted average change from baseline) in patients with high viral load (defined as greater than107 copies/mL) was a 0.68 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p<0.0001). There was a 1.08 log greater reduction with REGN-COV2 treatment by day 5, which corresponds to REGN-COV2 patients having, on average, a greater than 10-fold reduction in viral load, compared to placebo.
• In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p=0.0003).
• As in the earlier analysis, patients with higher viral load at baseline and/or no detectable antibodies at baseline (suggesting their bodies had not yet mounted an effective immune response), derived greater benefit from REGN-COV2 therapy.

Clinical results in the overall population (n=799):

• On the key clinical endpoint, treatment with REGN-COV2 reduced COVID-19 related medical visits by 57% through day 29 (2.8% combined dose groups; 6.5% placebo; p=0.024).
• Treatment with REGN-COV2 reduced COVID-19 related medical visits by 72% in patients with one or more risk factor (including being over 50 years of age; body mass index greater than 30; cardiovascular, metabolic, lung, liver or kidney disease; or immunocompromised status) (combined dose groups; nominal p = 0.0065).

Really like your weather posts but now you are getting carried away with yourself - Have a nice martini and watch caddy shack.

 

[goru7]

Statistical significance is generally assumed for p-values of <0.05, not <0.005, so you're simply wrong on this, meaning Regeneron's data are statistically significant for reducing medical visits and reducing viral loads vs. placebo, as per the excerpt below. My post linked below has a whole write-up of statistical significance and p-values, including links to the primary research on what p-values mean and how 0.05 was arrived at.

And we've simply yet to see any clinical data of significance for leronlimab and COVID, because it doesn't exist yet. I hope it's beneficial, but I'm not particularly optimistic - we should know their phase IIb/III results (390 patients; they did just get the go-ahead to complete the trial in severe/critical patients at the interim analysis after 50% of the patients had been enrolled - this was just a safety check point though, not efficacy) by the end of the year, although many are bearish on leronlimab, including Seeking Alpha.

https://seekingalpha.com/news/36235...-for-covidminus-19-passes-first-safety-review

https://rutgers.forums.rivals.com/t...es-interventions-and-more.198855/post-4638962

Virologic results (n=524, prospectively confirming previous 275-patient analysis):

• On the primary endpoint, the average daily change in viral load through day 7 (mean time-weighted average change from baseline) in patients with high viral load (defined as greater than107 copies/mL) was a 0.68 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p<0.0001). There was a 1.08 log greater reduction with REGN-COV2 treatment by day 5, which corresponds to REGN-COV2 patients having, on average, a greater than 10-fold reduction in viral load, compared to placebo.
• In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p=0.0003).
• As in the earlier analysis, patients with higher viral load at baseline and/or no detectable antibodies at baseline (suggesting their bodies had not yet mounted an effective immune response), derived greater benefit from REGN-COV2 therapy.

Clinical results in the overall population (n=799):

• On the key clinical endpoint, treatment with REGN-COV2 reduced COVID-19 related medical visits by 57% through day 29 (2.8% combined dose groups; 6.5% placebo; p=0.024).
• Treatment with REGN-COV2 reduced COVID-19 related medical visits by 72% in patients with one or more risk factor (including being over 50 years of age; body mass index greater than 30; cardiovascular, metabolic, lung, liver or kidney disease; or immunocompromised status) (combined dose groups; nominal p = 0.0065).

Once again you are wrong. The DSMB first look at the severe /critical trial at 149 patients was a safety look. Pass with flying colors. The next look at 195 patients was an efficacy look. Passed again , no stoppage or change of trial. Why would the DSMB ask for another look at 293 patients when the trial is designed for 390 patients. The only conclusion is that although it is critically significant it would not be statistically significant until 293. Extremely unusual for DSMB to suggest a look at lower numbers instead of adding more patients to increase chances of statistical significance . What is your take ?

 

[goru7]

I posted on the market thread asking where the CYDY guy was. Good to see he's back.

Also interesting to see that the promises of "patients are enrolled and drug will be approved in two weeks" that we heard quite literally in multiple threads back in June hasn't come to fruition. But now, instead of a wierd CEO, being months behind schedule, and the fact that mexhanistically there is zero logic why anti-CC5 would directly impact viral load, it's simply due to big pharma buying their way to the top. Oh, and FDA shadiness (despite no differences in EMA, MHRA, etc.). Got it.

Why do you think Leronlimab has not been approved for at least EUA yet when there has not been a negative impact of the drug in any trial, or EINd patients or over 1000 AIDS patients, so totally safe with no side effects. Enlighten us with your reasons !