Glenmark to start clinical trial to test potential COVID-19 drug combination

Mumbai: Pharma major Glenmark Pharmaceuticals 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 a different mechanism of action, and their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during an early stage of the disease,  according to a press statement.

Early administration of the 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. 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 recognised as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity that is required for viral replication.

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 inhibitory.  Additionally, it exhibits modulatory effects 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. Both Favipiravir and Umifenovir inhibited virus infection in vitro5,6 and have shown efficacy in COVID-19 clinical trials. 

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.

Commenting on this development, 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 an overall improvement in clinical parameters. We consider Glenmark’s study will be pivotal in leading to the 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.” 

Further, Sujesh Vasudevan, President, India Formulations, Middle East and Africa business, Glenmark Pharmaceuticals Ltd 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.”

The monotherapy phase 3 clinical trial results are expected by July-August 2020.