Glenmark to conduct phase-3 ‘FAITH’ trial in hospitalised patients with moderate COVID-19 infection

Glenmark to commence new phase 3 clinical trial on combination of two anti-viral drugs in hospitalised patients of moderate COVID-19 in India

Updated - May 26, 2020 06:32 pm IST

Published - May 26, 2020 01:58 pm IST

Representational image.

Representational image.

As the number of COVID-19 patients are rising in India, Glenmark Pharmaceuticals Ltd has 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.

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 stage of disease, the company said in a statement.

Also read:Glenmark begins Phase-3 clinical trials on antiviral drug Favipiravir for COVID-19 patients in India

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, the statement added.

“Thus combining antiviral drugs could result in greater clinical effectiveness and could also prevent, or delay, the emergence of resistance,” the statement said.

Data | When are COVID-19 patients most likely to infect others?

Favipiravir is an oral antiviral drug approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action by which it inhibits viral replication.

It is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity that is required for viral replications.

Umifenovir is another oral antiviral drug licensed for the treatment of influenza A and B infections in Russia and China.

It impedes the viral attachment to cells and acts as a viral entry inhibitor.

Additionally, it exhibits modulatory effects, the company said.

The current Glenmark study will examine whether early administration of a combination of Favipiravir and Umifenovir, both acting by different mechanisms, enhances antiviral efficacy on COVID-19 patients on the immune system and induces interferon-production.

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, Vice President & 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.”

“We consider Glenmark’s study will be pivotal in leading to identification of highly effective and safe treatments against COVID-19 in India. Beyond its many potential patient treatment benefits, we also hope the combination therapy will reduce infection risk amongst medical professionals and healthcare workers by reducing the duration of virus shedding from treated patients,” she said.

Sujesh Vasudevan, President, India Formulations, Middle East and Africa business, Glenmark Pharmaceuticals Ltd said, “This is another step in our effort to launch a treatment for COVID-19 patients and we are looking at every possibility. 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 – Favipiravir plus Um I fenovir (efficacy & safety) Trial in Indian Hospital setting.

158 hospitalized patients of moderate COVID-19 infection will be enrolled in the combination study and randomized 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 having 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, Glenmark said in the statement.

Simultaneously Glenmark is also conducting phase 3 clinical trials of Favipiravir as a COVID-19 monotherapy option with 150 patients, enrolled from 9 leading government and private hospitals across the country. So far 30 patients have been randomised, the company said.

The monotherapy phase 3 clinical trial results are expected by July/August 2020, it added.

Glenmark was the first pharmaceutical company to receive approval from drug regulator DCGI to conduct Favipiravir clinical trials against COVID-19 in India.

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