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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

South Korean Olympic table tennis team player Lee Sang-su receiving the first dose of the Pfizer/BioNTech Covid-19 coronavirus vaccine in Seoul (Chung Sung-Jun/Pool Photo via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech do­nate their vac­cine to the Tokyo Olympics; No­vavax, Pfiz­er/BioN­Tech vac­cines ap­pear to be less ef­fec­tive against vari­ants

The long-delayed 2020 Olympics in Tokyo will feature gymnast Simone Biles in what is likely her last Summer Games, and skateboarder Nyjah Huston in what will be his first. But the players with the most impact on the games could be Pfizer and BioNTech. After a meeting between Pfizer CEO Albert Bourla and Japan’s Prime Minister Yoshihide Suga, a plan has been outlined to donate doses of their Covid-19 vaccine for the Olympic Games.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.