Re­searchers shut­ter 2 Covid-19 stud­ies as mon­i­tors flag Eli Lil­ly an­ti­bod­ies as a flop for pneu­mo­nia, hos­pi­tal­ized pa­tients — but EUA hunt con­tin­ues

Two weeks af­ter the safe­ty da­ta mon­i­tor­ing group ad­vised re­searchers to hit the hold but­ton on a clin­i­cal tri­al of Eli Lil­ly’s an­ti­body bam­lanivimab (LY­CoV55) for pa­tients hos­pi­tal­ized with Covid-19, the tri­al over­seers are back with fresh di­rec­tions to shut­ter the study af­ter los­ing faith that the drug could help this group of pa­tients.

The mon­i­tors con­clud­ed, how­ev­er, that there were no safe­ty is­sues in­volved, which will like­ly en­cour­age con­tin­ued be­lief that Lil­ly can still nail down an emer­gency mar­ket­ing ap­pli­ca­tion for less-sick pa­tients.

On Tues­day morn­ing, Lil­ly fol­lowed up with more bad news about their cost­ly Covid-19 ef­forts, which hit their top-line num­bers for Q3. A Phase II study for LY3127804, an ex­per­i­men­tal an­ti­body tar­get­ing An­giopoi­etin 2, was dropped from the pipeline, with­out ex­pla­na­tion. The move to yank the study was not­ed in their chart on the up­dat­ed pipeline.

Re­searchers were study­ing the drug for pneu­mo­nia pa­tients hos­pi­tal­ized with COVID-19 on the the­o­ry that in­hibit­ing Ang2 would re­duce the need for ven­ti­la­tion. In re­sponse to a query, a Lil­ly spokesper­son told me the pro­gram was halt­ed in Sep­tem­ber due to fu­til­i­ty. There were no safe­ty is­sues in­volved.

Lil­ly’s shares were down more than 5% Tues­day, ahead of the bell.

In a state­ment on the bam­lanivimab move, Lil­ly not­ed:

Based on an up­dat­ed dataset from the tri­al re­viewed on Oc­to­ber 26, no ad­di­tion­al COVID-19 pa­tients in this hos­pi­tal­ized set­ting will re­ceive bam­lanivimab. This rec­om­men­da­tion was based on tri­al da­ta sug­gest­ing that bam­lanivimab is un­like­ly to help hos­pi­tal­ized COVID-19 pa­tients re­cov­er from this ad­vanced stage of their dis­ease. In this up­dat­ed dataset, dif­fer­ences in safe­ty out­comes be­tween the groups were not sig­nif­i­cant.

The orig­i­nal halt to the study — part of a mas­ter pro­to­col ef­fort dubbed AC­TIV-3 run by the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases that com­bined the an­ti­body with Gilead’s remde­sivir — came about af­ter one group in the study ap­peared to do bet­ter than an­oth­er, though the com­pa­ny nev­er iden­ti­fied which group.

Now, Lil­ly says that while the monother­a­py added to oth­er drugs doesn’t ap­pear to help hos­pi­tal­ized pa­tients, they say they “re­main con­fi­dent based on da­ta from Lil­ly’s BLAZE-1 study that bam­lanivimab monother­a­py may pre­vent pro­gres­sion of dis­ease for those ear­li­er in the course of COVID-19.”

Da­ta from that BLAZE-1 Phase II study are be­ing used to back Lil­ly’s ap­pli­ca­tion for an emer­gency use au­tho­riza­tion. And Pres­i­dent Trump has al­ready tout­ed the drug as a ver­i­ta­ble cure.

There are sev­er­al on­go­ing stud­ies, in­clud­ing BLAZE-1. The oth­er 2:

— AC­TIV-2, the NIH-spon­sored study in re­cent­ly di­ag­nosed mild to mod­er­ate Covid-19 pa­tients.

— BLAZE-2, Lil­ly’s Phase III study of bam­lanivimab for the pre­ven­tion of Covid-19 in res­i­dents and staff at long-term care fa­cil­i­ties.

The tri­al da­ta for the first round of drugs aimed at Covid-19 have of­fered a mixed batch of pos­i­tive and neg­a­tive re­sults.

Gilead was the first to get an EUA for remde­sivir, and the first to get full ap­proval. But it al­so won the OK af­ter a WHO study con­clud­ed that the drug did not im­prove mor­tal­i­ty rates.

Lil­ly has had to con­tend with oth­er set­backs as well, in­clud­ing re­ports that the man­u­fac­tur­ing fa­cil­i­ty that makes its an­ti­body was cit­ed for se­ri­ous qual­i­ty con­trol con­cerns. The an­ti­body bam­lanivimab was de­vel­oped orig­i­nal­ly by Ab­Cellera and then part­nered with Lil­ly.

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

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.