Glenmark on Tuesday announced that it would conduct a new randomized, open-label study to test the combined efficacy of two antiviral drugs Favipiravir and Umifenovir as a potential COVID19 treatment strategy.
Favipiravir is an oral antiviral drug approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections.
Umifenovir is another oral antiviral drug licensed for the treatment and prophylaxis of influenza A and B infections in Russia and China.
“The two antiviral drugs have different mechanism of action, and their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during early stage of disease,” Glenmark said in a statement.
Monika Tandon, vice-president and head for Clinical Development Global Specialty and Branded Portfolio, Glenmark Pharmaceuticals Ltd, said, “Combining antiviral agents that have a good safety profile and act on different stages of viral life-cycle is an effective treatment approach to rapidly suppress initial high viral load and lead to overall improvement in clinical parameters.”
“We consider Glenmark’s study will be pivotal in leading to identification of highly effective and safe treatments against COVID-19 in India,” said Tandon.
“Beyond its many potential patient treatment benefits, we also hope the combination therapy will reduce infection risk amongst medical professionals and healthcare workers by reducing the duration of virus shedding from treated patients,” she added.
A total of 158 hospitalized patients of moderate COVID-19 infection will be enrolled in the combination study and randomized in two groups.
“One group will be receiving Favipiravir and Umifenovir (with standard supportive care) and another will be receiving only Favipiravir along with standard supportive care,” the company stated.
Meanwhile, Glenmark is also conducting phase 3 clinical trials of Favipiravir as a COVID-19 monotherapy option with 150 patients, enrolled from 9 leading government and private hospitals across the country.
So far 30 patients have been randomized, it added.