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

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.

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