Glenmark will conduct a phase 3 trial in India, testing the efficacy of antivirals favipiravir and umifenovir for the treatment of COVID-19.
The trial will examine if early administration of the drug combination will enhance efficacy in 158 hospitalized patients with moderate COVID-19, who will be randomized to receive either favipiravir with or without umifenovir along with the standard of care. The company did not give a timeframe for trial results.
The company is also conducting phase 3 trials of favipiravir as a COVID-19 monotherapy in 150 patients from nine hospitals across India. The results of that trial are expected by July or August.
Favipiravir, marketed by Fujifilm under the brand name Avigan, has been approved in Japan since 2014 for treating influenza. Japan’s health minister announced Tuesday that the country does not expect to approve the drug this month for COVID-19 as previously planned, after interim clinical trial results showed no clear evidence of efficacy. But the drug is still under review.
Umifenovir, sold under the brand name Arbidol, is used to treat influenza in China and Russia but has not received approval elsewhere. — James Miessler