“FDA anoints Gilead's remdesivir as the Covid-19 treatment winner, handing down full approval — despite some deep skepticism - Endpoints News” plus 1 more

“FDA anoints Gilead's remdesivir as the Covid-19 treatment winner, handing down full approval — despite some deep skepticism - Endpoints News” plus 1 more

FDA anoints Gilead's remdesivir as the Covid-19 treatment winner, handing down full approval — despite some deep skepticism - Endpoints News

Posted: 22 Oct 2020 02:09 PM PDT

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his "Cancer Moonshot," but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Regeneron posts second look on Covid-19 antibody cocktail, boosting its case for EUA — but what about symptom alleviation? - Endpoints News

Posted: 29 Oct 2020 03:36 AM PDT

Re­gen­eron has re­vealed a sec­ond cut of da­ta on its Covid-19 an­ti­body cock­tail in the out­pa­tient set­ting — da­ta that it has sent straight to the FDA to boost its emer­gency use au­tho­riza­tion re­quest.

The new re­sults re­in­force what's re­port­ed from the same tri­al last month, Re­gen­eron said, in­cor­po­rat­ing a to­tal of 799 non-hos­pi­tal­ized pa­tients with mild-to-mod­er­ate dis­ease. REGN-COV2 re­duced vi­ral load and pa­tient med­ical vis­its (any­thing rang­ing from hos­pi­tal­iza­tions, emer­gency room, ur­gent care vis­its to physi­cian of­fice and telemed­i­cine vis­its), meet­ing all the key end­points.

George Yan­copou­los

No­tably, there ap­pears to be no sig­nif­i­cant dif­fer­ence be­tween the high and low dos­es, spurring Re­gen­eron to con­sid­er chang­ing dos­ing in the on­go­ing tri­al giv­en lim­it­ed sup­ply.

Num­bers on the key met­ric of symp­tom al­le­vi­a­tion, how­ev­er, are con­spic­u­ous­ly miss­ing. And that is lead­ing an­a­lysts to ask ques­tions about the drug's fu­ture as Re­gen­eron squares up with Eli Lil­ly and a host of de­vel­op­ers com­ing from be­hind.

"We ex­pect these re­sults will jus­ti­fy an EUA, con­sid­er­ing where that hur­dle seems to be, but we would re­al­ly like to have seen more de­fin­i­tive da­ta on things such as qual­i­ty of life and hos­pi­tal­iza­tions giv­en how the ben­e­fit on symp­toms seemed to fade with the ex­pand­ed pa­tient num­bers," Baird an­a­lyst Bri­an Sko­r­ney wrote.

Here's what we do know: REGN-COV2 in­duced, on av­er­age, a greater than 10-fold re­duc­tion in vi­ral load com­pared to place­bo, with a dif­fer­ence of 0.68 log10 copies/mL in the av­er­age dai­ly change through day 7 for pa­tients with high vi­ral load. At the in­ter­im with 275 pa­tients, the co­horts saw a 0.37 log10 re­duc­tion through day 7.

Through 29 days, on­ly 2.8% of pa­tients tak­ing the an­ti­bod­ies — whether it's the 8g or 2.4g dos­es — end­ed up hav­ing a med­ical vis­it com­pared to 6.5% on place­bo, trans­lat­ing to a re­duc­tion of 57% (p=0.024). The ef­fect was more pro­nounced among those with one or more risk fac­tors, with treat­ment re­duc­ing med­ical vis­its by 72%.

Spot­light­ing vul­ner­a­ble groups has been a key talk­ing point for Re­gen­eron ex­ecs, who tout­ed pos­i­tive re­sults from seroneg­a­tive pa­tients at the last read­out.

"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," CSO George Yan­copou­los said in a state­ment.

Sko­r­ney sees an­oth­er en­cour­ag­ing sign in the trend to low­er se­ri­ous ad­verse events in the an­ti­body arm. The rate of se­ri­ous ad­verse events was 0.8% for high dose, 1.6% for low dose and 2.3% for place­bo.

Biren Amin of Jef­feries sim­i­lar­ly pre­dict­ed that the re­sults would ce­ment Re­gen­eron's EUA, not­ing that con­sis­tent vi­ral load low­er­ing is a promis­ing sig­nal of ef­fi­ca­cy. But he sin­gled out Re­gen­eron's dis­clo­sure that, with no planned sta­tis­ti­cal analy­sis of al­le­vi­a­tion, in­ves­ti­ga­tors al­so didn't ob­serve "ro­bust as­so­ci­a­tions with vi­ral load, serol­o­gy sta­tus or treat­ment."

"The dis­crep­an­cy be­tween a lack of symp­tom al­le­vi­a­tion and re­duced med­ical vis­its in the lat­est da­ta cut is puz­zling es­pe­cial­ly in light of LY-CoV555 da­ta where it has shown low­er symp­toms, low­er vi­ral load, and low­er hos­pi­tal­iza­tions," he wrote. "The LLY da­ta has al­so shown re­duc­tions in hos­pi­tal­iza­tions in high-risk groups of 71%."

Re­gen­eron and Eli Lil­ly are the first com­pa­nies to seek au­tho­riza­tion for their Covid-19 an­ti­bod­ies, both fo­cus­ing ini­tial­ly on the out­pa­tient set­ting. While the first rounds of da­ta on REGN-COV2 and Lil­ly's sin­gle an­ti­body drew mixed re­ac­tions, Lil­ly man­aged to im­press with a cock­tail com­bin­ing two dif­fer­ent an­ti­bod­ies from Cana­da's Ab­Cellera (bam­lanivimab) and Shang­hai-based biotech Jun­shi Bio­sciences (ete­se­vimab).

Hav­ing scored a $450 mil­lion con­tract from Op­er­a­tion Warp Speed to ramp up man­u­fac­tur­ing, Re­gen­eron has oth­er tri­als un­der­way to test its drug among hos­pi­tal­ized pa­tients — a set­ting where Lil­ly has re­cent­ly con­tend­ed with a flop — and for pre­ven­tion. Oth­er play­ers like Glax­o­SmithK­line-backed Vir and Ada­gio are catch­ing up.

Pres­i­dent Don­ald Trump, who took REGN-COV2, has tout­ed both as "cures" and promised a quick OK in ear­ly Oc­to­ber. The FDA has yet to make a de­ci­sion.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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