Glenmark starts Phase 3 clinical trials on potential COVID-19 drug in India

New Delhi: Glenmark Pharmaceuticals said on Tuesday it has initiated clinical trials in India of antiviral drug favipiravir, seen as a potential treatment for the coronavirus disease (Covid-19), for which it received approval from the country’s drug regulator in April.

Mumbai-based Glenmark said in a BSE filing the approval made it the first pharmaceutical company in India to be given the nod by the Drug Controller General of India to start trials on Covid-19 patients.

Favipiravir is manufactured under the brand name Avigan by Fujifilm Toyama Chemical Co Ltd, a subsidiary of Japan’s Fujifilm Holdings Corporation, and approved for use as an anti-flu drug in the country in 2014.

Glenmark said clinical trials have begun and more than 10 leading government and private hospitals in India are being enrolled for the study. It estimates the study completion by July or August this year.

The company said it has successfully developed API and the formulations for the product through its in house research and development team.

“Several health and medical experts, both in and outside of Glenmark, are eager to see the effect that Favipiravir has on COVID-19 cases. We believe the study results will be significant as there is currently no effective treatment for the virus,” Dr Monika Tandon, vice president and head of clinical development, said in a BSE filing.

“The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management,” Tandon added.

India’s tally of Covid-19 stood at 70,756 on Tuesday morning with 2293 fatalities across the country, according to the health ministry’s Covid-19 dashboard.

The Phase 3 clinical trials come after a Chinese official told reporters in April that an active ingredient of the drug had been effective, with no obvious side effects, in helping patients of the coronavirus disease recover.

Drugmakers across the world have been rushing to develop a treatment or vaccine for the fast-spreading coronavirus that has affected more than four million people and killed 286,330 across the world and ravaged financial markets.

Early clinical trial results last week from Gilead Sciences Inc’s experimental antiviral drug remdesivir showed it helped patients recover more quickly from the illness caused by the coronavirus.

Strides Pharma Science Ltd, another Indian pharmaceutical company, said last week it had developed and commercialised favipiravir antiviral tablets, and had applied to the authorities to start trials.