Glenmark begins phase 3 clinical trials of favipiravir
NEWDELHI: Glenmark Pharmaceuticals Limited has started the process of conducting phase 3 clinical trials of Favipiravir among Covid-19 patients in India to test the safety and efficacy of the drug.
According to a Glenmark staffer 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 commercialised, 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,” the company said in a statement.
Favipiravir is an antiviral 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 the trials.
“Several experts, both in and outside of Glenmark, are eager to see the effect that Favipiravir has. 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 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,” 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.