Novartis AG will push forward with a potential medicine for COVID-19 after promising results showing a lower risk of bad outcomes for patients who took the antiviral in a mid-sized study.
COVID patients who took the therapy, ensovibep, had a 78 per cent lower risk of needing an emergency health-care visit, being hospitalized or dying in the 407-person test, the companies said Monday. The compound also cleared the main hurdle of the study, which was to reduce the amount of virus in the body over eight days.
Novartis said it’s exercising an option to license ensovibep from its Swiss partner Molecular Partners AG, which will receive a payment of 150 million francs (US$163 million). Novartis is becoming responsible for developing, manufacturing and selling the therapy.
If it’s approved, Novartis’s antiviral would be the first to attack the coronavirus’s spike protein in multiple ways, potentially making it more effective against a range of current and future variants. That could make it a useful addition to the growing arsenal of COVID therapies, after some antibody treatments have proven less effective against the omicron variant.
Molecular Partners shares surged as much as 34 per cent, the most in more than a year. Novartis shares rose 0.6 per cent.
Unlike antiviral pills from Pfizer Inc. and Merck & Co., Novartis’s medicine is given via an intravenous infusion, making a doctor’s visit necessary. The drugmaker said it will share the data with regulators this month and start a larger trial to confirm the results as soon as possible.
The companies said that a lab study showed ensovibep should also be able to neutralize omicron. Novartis said it plans to enroll 1,700 patients around the world for the further study of the compound.
Ensovibep is what’s known as a DARPin, a new class of drugs. They’re similar in some ways to monoclonal antibodies, medicines produced in cells that are used to treat a range of diseases including cancer and Covid. But DARPin compounds can be made more simply, using bacteria, meaning more doses could be available sooner than is the case for traditional monoclonal antibodies.
What Bloomberg Intelligence Says:
“It’s very encouraging that Novartis and Molecular Partners’ Phase II ensovibep antiviral trial shows a 78 per cent reduction in the risk of hospitalization, emergency-room visits or death from COVID-19, but we need much more detail to assess its commercial and pandemic potential. The key issue is that using an intravenous drug isn’t possible in the broad population, so as such, data in patients with higher risks of developing severe Covid-19 is needed. Other questions include the lack of a dose response, meaning a lower dose than 75 mg could also work. There’s also a lack of safety data, the risk of anti-drug antibodies on repeated use and the effect of the timing of dosing vs. symptom onset.”
-- Sam Fazeli, BI pharma analyst
The ability to make very large volumes at “hopefully much lower cost” could help Novartis bring DARPin therapies to a broader population around the world, Novartis Chief Executive Officer Vas Narasimhan said at last year’s J.P. Morgan Health Care Conference.