Glenmark Pharmaceuticals has initiated late-stage Phase-III clinical trials on the antiviral Favipiravir to test its efficacy in patients showing mild-to moderate symptoms of the Covid-19 infection.

The company had received approvals from the Drug Controller General of India (DCGI) in late April. It expects to complete the study by July/August 2020.

Favipiravir is a generic version of Avigan of Japan’s Fujifilm Toyama Chemical Co Ltd, a subsidiary of Fujifilm Corporation. Studies are on in multiple countries on this drug, as well as other medicines and vaccines towards finding effective treatment against the virus.

Clinical trials have commenced, and over 10 leading government and private hospitals in India are being enrolled for the study, Glenmark said. The company has developed the active pharmaceutical ingredient and formulations for the product through its inhouse research team.

“As per the approved clinical trial protocol, 150 subjects with mild-to-moderate Covid-19 will be randomised in the study in a 1:1 ratio to Favipiravir, with standard supportive care or standalone standard supportive care. Treatment duration is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomisation,” the Mumbai-based drugmaker said.

Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections,” Glenmark said, adding that the molecule, if commercialised, would be marketed as ‘FabiFlu®’ in India.

Other Indian companies in the fray on favipiravir include Cipla, who is in collaboration with the Council of Scientific and Industrial Research’s Indian Institute of Chemical Technology. Strides Pharma had said last month that it had commercialised the product and exported it.

Monika Tandon, Glenmark’s Vice President and Head, Clinical Development (Global Specialty/Branded Portfolio), said the study results would be significant and give greater clarity on treatment and management of the infection, since there is currently no effective treatment against the virus. Sujesh Vasudevan, Glenmark Pharmaceuticals President (India Formulations, Middle East and Africa) said they would ensure access to the product across the country if trials were successful.

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