Glenmark To Begin Phase 3 Clinical Trial On Combo Of Two Antiviral Drugs In Moderate Covid-19 Patients

Mumbai-based Glenmark Pharmaceuticals on Tuesday (26 May) 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 company said in a statement.

“The two antiviral drugs have different mechanism of action, and their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during early stage of disease,” Glenmark said in the 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. Thus combining antiviral drugs could result in greater clinical effectiveness and could also prevent, or delay, the emergence of resistance.

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. 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, the company said.

Glenmark said that its new 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.

Dr Monika Tandon, Vice President & Head, Clinical Development Global Specialty and 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,” she said.

“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,” Tandon added.

The new combination clinical trial will be called FAITH – (FA vipiravir plus Um I fenovir (efficacy & safety) T rial in Indian H ospital setting), the company said.

A total of 158 hospitalized patients of moderate COVID-19 infection will be enrolled in the combination study and randomized into two groups: one group receiving Favipiravir and Umifenovir (with standard supportive care); and one group receiving Favipiravir along with standard supportive care.

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 monotherapy phase 3 clinical trial results are expected by July or August 2020, the company said.

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