Glenmark Pharmaceuticals, a research focused drugmaker, has started Phase-3 clinical trials of antiviral molecule favipiravir to treat coronavirus patients in India. The Mumbai-based company had in April received approval from the Drug Controller General of India for testing this drug in COVID-19 patients.
First company to conduct human trials on favipiravir against COVID infection in India, Glenmark said that over 10 leading government and private hospitals in the country are being enrolled for the drug study.
According to Glenmark, the clinical study is estimated to be completed by July/August 2020. As per the approved clinical trial protocol, 150 subjects (patients) with mild to moderate COVID-19 will be randomized 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 randomization, the company said on Tuesday.
Favipiravir has demonstrated effect against influenza viruses and it has been approved in Japan for the treatment of novel influenza virus infections. Fujifilm Toyama Chemical Co., a subsidiary of Japanese conglomerate Fujifilm Corporation, is currently selling this drug in that market under the brand name Avigan.
Glenmark developed this active pharma ingredient and the formulation here for the trials through its in- house research and development team. If successful in the trials and duly approved for marketing, Glenmark will sell this molecule under the brand name ‘FabiFlu’ in India.
“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,” said Dr. Monika Tandon, vice president & head, Clinical Development (Global Specialty/Branded Portfolio) at Glenmark Pharmaceuticals.
“The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management,” she added.
According to Sujesh Vasudevan, president (India Formulations, Middle East and Africa), at Glenmark Pharmaceuticals, the company’s effort is to launch a treatment for COVID-19 patients as soon as possible and control the spread of the pandemic.
“We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful,” Vasudevan said.