On Tuesday, Glenmark Pharmaceuticals announced that it will undertake another new Phase 3 clinical trial on a combination of two anti-viral drugs Favipiravir and Umifenovir. Glenmark has received approval from the Drugs Controller General of India (DCGI) to initiate the study.
The combination of two anti-viral drugs study is called the FAITH trial which will enlist 158 hospitalized patients with a moderate level of CVOID-19 infection. In the trial, the patient will receive Faviprivir 1800 mg bid and Umifenovir 800 mg bid on Day 1. Afterwards, patients would receive Faviprivir 800 mg bid and Unifenovir 800 mg bid for the remaining course of the 14 days treatment. Patients will get discharged after clinical cure and two consecutive negative tests for COVID-19
Combination study is emerging as an efficacious approach in shortening duration of virus shedding, decreasing cytokine response, and facilitating early discharge of patients. The antivirals with different dynamics could complement and enhance efficacy against COVID-19. Simultaneously, Glenmark is also conducting its Phase 3 clinical trials on antiviral Favipiravir mono-therapy for COVID-19 patients in India.
Favipiravir is an oral antiviral drug approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. Umifenovir is another oral antiviral drug licensed for the treatment and prophylaxis of influenza A and B infections in Russia and China. Hence a combined use of Favipiravir and Umifenovir of different dynamics offers a thorough antiviral cover on pre-entry and post-entry life-cycle of the SARS-CoV-2 virus.
President of India Formulations, Middle East and Africa business, Glenmark Pharmaceuticals Ltd. Sujesh Vasudevan, mentioned “This is another step in our effort is to launch a treatment for COVID-19 patients and we are looking at every possibility. We will do all it takes to ensure the accessibility of the product across the country if the clinical trials are successful.”
Glenmark was the first pharmaceutical company to receive approval from drug regulator DCGI to conduct Favipiravir clinical trials against COVID-19 in India.
