Glenmark begins phase 3 clinical trials of favipiravir
Glenmark Pharmaceuticals Limited has started the process of conducting phase 3 clinical trials of Favipiravir among Coronavirus disease (Covid-19) patients in India to test the safety and efficacy of the antiviral drug, the company said on Tuesday.
According to Glenmark executives familiar with the development, who didn’t want to be named, the company will be looking at recruiting patients from hospitals in the red zones of states such as Gujarat, Maharashtra and Delhi where the Covid-19 case load is high.
The drug, if commercialized, will be marketed under the brand name ‘FabiFlu®’ in India.
Glenmark is looking at enrolling patients from at least 10 government and private hospitals from across the country for conducting the trials, and is expecting results by either July or August.
“Glenmark is the first company in India to initiate Phase 3 clinical trials on Favipiravir for Covid-19 patients in India. Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation. Clinical trials have commenced and over 10 leading government & private hospitals in India are being enrolled for the study. Glenmark estimates study completion by July/August 2020,” the company said in a statement.
Favipiravir is an antiviral medicine used to treat influenza in Japan. What Glenmark is producing is a generic version of Avigan. It has successfully developed the active pharmaceutical ingredient (API) and the formulations for the product through its in-house research and development team.
Japan’s Prime Minister Shinzo Abe has been pushing the benefits of Avigan and built a huge inventory of it, despite there being no evidence as yet that the drug, which was developed as a possible cure for Ebola, works on curing any disease in humans.
Glenmark received approval from India’s drug regulator general on April 30 for conducting the trials.
“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 Monika Tandon, vice president and head, clinical development, Glenmark Pharmaceuticals.
In the past few months, after the outbreak of Covid-19, multiple clinical trials have been initiated on Covid-19 patients in China, Japan and the US.
“The data we get from these trials will point us in a clearer direction with regard to Covid-19 treatment and management,” Tandon added.
As per the approved clinical trial protocol, 150 subjects 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, which is the process of assiging patients to groups that recieve different treatments.
“Our 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,” said Sujesh Vasudevan, president, India formulations, Middle East and Africa, Glenmark.