PP_1170x120_10-25-21

Glenmark to commence new phase 3 clinical trial for COVID-19 in India

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MUMBAI, India — Glenmark Pharmaceuticals announced a new randomized, open-label study to test the combined efficacy of two antiviral drugs Favipiravir and Umifenovir as a potential COVID-19 treatment strategy.

Favipiravir is an oral antiviral drug approved in Japan since 2014. It has a unique mechanism of action by which it inhibits viral replication: Umifenovir is another oral antiviral drug licensed for treatment and prophylaxis of influenza A and B infections in Russia and China. Umifenovir impedes the viral attachment to cells and acts as a viral entry inhibitor. Additionally it exhibits modulatory effects on the immune system and induces interferon-production. Hence combined use of Favipiravir and Umifenovir acting on different mechanisms offers a comprehensive antiviral cover on pre-entry and post-entry life-cycle of the SARS-CoV-2 virus. Both antivirals inhibited virus infection in vitro and have shown efficacy in COVID-19 clinical trials. The current Glenmark study will examine whether early administration of this combination, both acting by different mechanisms, enhances antiviral efficacy on COVID-19 patients.

The new combination clinical trial will be called FAITH – (FA vipiravir plus Um I fenovir (efficacy & safety) T rial in Indian H ospital setting). 158 hospitalized patients of moderate COVID-19 infection will be enrolled in the combination study and randomized in two groups: one group receiving Favipiravir and Umifenovir (with standard supportive care); and one group receiving Favipiravir along with standard supportive care. Patients in the arm receiving the drug will receive Faviprivir 1800mg bid and Umifenovir 800 mg bid on Day 1. Thereafter patients would receive Faviprivir 800mg bid and Unifenovir 800mg bid for the remaining course of the treatment. Duration of treatment will be 14 days and patients will be discharged after clinical cure and two consecutive negative tests for COVID-19 based on RT-PCR.


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