Covid-19 roundup: AstraZeneca's Farxiga fails PhIII test; Supply deal for Eli Lilly's solo bamlanivimab officially canceled

12 Apr 2021
endpts.com
VaccineCollaborateAntibodyEmergency Use AuthorizationmRNA
Around the same time AstraZeneca struck up a vaccine partnership with Oxford last April, the pharma giant also put together a game plan to develop treatments — both new and repurposed — for Covid-19. One of them has now ended in failure. The Phase III DARE-19 trial recruited 1,250 patients hospitalized with Covid-19 over the past year and gave half of them the diabetes drug Farxiga on top of standard of care therapy. When compared to those receiving placebo, the drug didn’t hit statistical significance in either of the primary endpoints: preventing measuring organ dysfunction and all cause mortality, or improving recovery (as measured by a change in clinical status) at 30 days. Focusing on the bright side, Mene Pangalos, EVP of biopharmaceuticals R&D, noted: “Prior to the DARE-19 Phase III trial, there was little data on the use of SGLT2 inhibitors in hospitalised patients with COVID-19 and we have now helped to fill this knowledge gap.” Mikhail Kosiborod, the principal investigator of the trial and the VP of research at AstraZeneca partner Saint Luke’s Mid America Heart Institute, echoed Pangalos and called the findings “very interesting and valuable.” Details are due to be released at the American College of Cardiology Scientific Sessions in May. While originally designed as a diabetes pill, Farxiga has been shown across large studies to have cardio and renal protective effects not just in that population but also for those with heart failure with reduced ejection fraction and chronic kidney disease (CKD). Coincidentally, scientists had observed that Covid-19 patients with “cardiac, renal and metabolic comorbidities” tended to have poor outcomes — leading AstraZeneca to test whether Farxiga may help in this setting as well. Like a slew of other commercial drugs that biopharma companies big and small tried to repurpose, it didn’t. AstraZeneca itself has already concluded that Calquence, the blockbuster BTK inhibitorBTK inhibitor approved for cancer, made little difference in mortality or saving Covid-19 patients from respiratory failure. While the pharma giant didn’t specify the next steps, it seems to imply that this will mark the end of the Farxiga program in Covid-19. Days after the US government and Eli Lilly agreed to halt all distribution of bamlanivimab as a monotherapy, the company said officials have officially revised the antibody supply deal. That means the purchase agreement for bamlanivimab will be terminated, the company said in a statement, canceling the planned delivery of 350,836 doses the original agreement had called for. Concerns of bamlanivimab’s diminished efficacy against certain coronavirus variants first led the US to stop direct ordering of bamlanivimab alone in three states , before extending that ban to the whole country. Instead, hospitals could order either bamlanivimab and etesevimab together or etesevimab alone to pair with any remaining doses of bamlanivimab on hand. The arrangement is now codified in the modified contract. First developed by AbCellera, bamlanivimab was the first monoclonal antibody to gain an emergency use authorization at the FDA. Lilly subsequently paired it with etesevimab, which originated from China’s Junshi, generating a solid slate of combo data that led to another EUA, also for mild to moderate Covid-19. Together, the two regimens were the subject of a $1.2 billion supply deal. As concerns grew that certain variants could evade antibody treatments, the FDA has directed both Lilly and Regeneron to monitor genomic database(s) for the emergence of global viral variants and track how well their drugs can tackle those variants. As Fosun Pharma prepares to push BioNTech’s Covid-19 vaccineCovid-19 vaccine toward an approval in China, a senior industry figure says homegrown mRNA players will also be ready to jump in the game soon. “We fully expect that there is a high possibility that a domestic mRNA vaccine will hit the market by this year,” Feng Duojia, president of the China Association of Vaccines, told the South China Morning Post. One candidate jointly developed by the Academy of Military Science, Walvax Biotechnology and Suzhou Abogen Biosciences has been through Phase II trials with “satisfactory” results, he said, with Phase III trials underway overseas. Another from Shanghai-based Stemirna went into the clinic last month. Fosun, meanwhile, is sorting through data from Phase II trials conducted in Jiangsu province, SCMP reported. The plan is to combine those with Phase III results from overseas in its regulatory filing. While Fosun started off as the developer and distributor of BioNTech’s vaccines — having started delivering doses made in Germany to Hong Kong and Macau — the company has inked a deal to produce locally. “The preparations at the production facility are ready,” Feng added. “After effective results are obtained through these trials, an application will be submitted to the relevant government agency immediately, with the hope to start domestic production of the foreign vaccine in China.” For a look at all Endpoints News coronavirus stories, check out our special news channel .
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