Glenmark to conduct ‘FAITH’ trials

One set of patients will receive Favipiravir and Umifenovir, and the other will get Favipiravir over 14-day period. reuters  

With the number of COVID-19 patients rising in India, Glenmark Pharmaceuticals Ltd., has announced a new randomised, open-label study to test the combined efficacy of two antiviral drugs — Favipiravir and Umifenovir — as a potential COVID-19 treatment strategy.

The two antiviral drugs have different mechanisms of action, and their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during early stages of the disease, the company said in a statement.

Early administration of a combination of antiviral medications acting by different mechanisms is desirable for the treatment of COVID-19, since the viral load of SARS-CoV-2 peaks around the time of symptom onset, it added.

The current Glenmark study will examine whether early administration of a combination of Favipiravir and Umifenovir enhances anti-viral efficacy on COVID-19 patients. Hence, a 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, the company said.

Both Favipiravir and Umifenovir inhibited virus infection in vitro and have shown efficacy in COVID-19 clinical trials. Dr. Monika Tandon, V-P & Head, Clinical Development Global Specialty / Branded Portfolio, Glenmark Pharmaceuticals Ltd., said, “Combining antiviral agents that have a good safety profile and act on different stages of viral life cycle is an effective treatment approach to rapidly suppress initial high viral load and lead to overall improvement in clinical parameters.” Sujesh Vasudevan, president, India Formulations, Middle East and Africa business, Glenmark Pharmaceuticals said, “This is another step in our effort to launch a treatment for COVID-19 patients. We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful.”

The new combination clinical trial will be called FAITH – (FA vipiravir plus Um I fenovir (efficacy and safety) Trial in Indian Hospital setting). As many as 158 hospitalised patients of moderate COVID-19 infection will be enrolled in the combination study and randomised in two groups.

While one group will be receiving Favipiravir and Umifenovir (with standard supportive care), the other group will receive Favipiravir along with standard supportive care. Patients taking the drug will receive Faviprivir 1800 mg bid and Umifenovir 800 mg bid on Day 1. Thereafter, they will receive Faviprivir 800mg bid and Unifenovir 800mg bid for the remaining course of treatment. Duration of treatment will be 14 days and patients will be discharged after clinical cure and two consecutive negative tests.

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Printable version | Oct 22, 2021 4:13:01 AM |

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