On Tuesday, Glenmark Pharmaceuticals said that it has initiated Phase-3 clinical trials of antiviral tablet Favipiravir, a potential drug for the Coronavirus after it received approval from the country’s drug regulator last month.
According to the reports, Glenmark is the first company in India to initiate Phase-3 clinical trials on Favipiravir for coronavirus patients in the country. Favipiravir is manufactured under the brand name Avigan by Fujifilm Toyama Chemical Co Ltd, a subsidiary of Japan’s Fujifilm Holdings Corporation. It was approved for use as an anti-flu drug in the country in 2014.
The drug company said that they have already started the clinical trials 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.
Favipiravir is an anti-viral agent that selectively and potently inhibits the RNA-dependent RNA polymerase (RdRp) of RNA viruses, like the Novel Coronavirus. Favipiravir undergoes an intracellular phosphoribosylation to be an active form, favipiravir-RTP (favipiravir ribofuranosyl-5′-triphosphate), which is recognized as a substrate by RdRp, and inhibits the RNA polymerase activity. Favipiravir is effective against a wide range of types and subtypes of influenza viruses, including strains resistant to existing anti-influenza drugs.
It may be noted that favipiravir shows anti-viral activities against other RNA viruses such as arenaviruses, bunyaviruses and filoviruses, all of which are known to cause fatal hemorrhagic fever. These unique anti-viral profiles will make favipiravir a potentially promising drug for specifically untreatable RNA viral infections.
To be commercialised under the name ‘FabiFlu’
The company said it has successfully developed API and the formulations for the product through its in house research and development team. The molecule will be marketed under the brand name ‘FabiFlu’ if commercialised in India.
Dr Monika Tandon, vice president and head of clinical development said, “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”.
She added that the data they get from these trials will point us in a clearer direction with regard to coronavirus treatment and management.
“We believe the study results will be significant as there is currently no effective treatment for the virus. The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management,” Tandon said.
As per the approved clinical trial protocol, 150 subjects with mild to moderate coronavirus will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. The duration of the treatment is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomisation.