Glenmark to study potential COVID-19 drug combination on Favipiravir, Umifenovir in India
New Delhi, May 26: Glenmark Pharmaceuticals Ltd said on Tuesday it will begin a new clinical trial in India to test a combination of two anti-viral drugs, favipiravir and umifenovir, as a potential COVID-19 treatment.
Glenmark has received approval from the Indian regulator to initiate the study.
The study dubbed 'FAITH trial' will look to enroll 158 hospitalized patients suffering from moderate COVID-19 infections in India, the company said.
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, said the pharma major 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. 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 recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity that is required for viral replication.4 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. Hence a combined use of Favipiravir and Umifenovir acting on different mechanisms offers a comprehensive antiviral cover on preentry 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.
Monika Tandon, Vice President and Head for Clinical Development Global Specialty and Branded Portfolio, 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."
Simultaneously, Glenmark is also conducting phase 3 clinical trials of Favipiravir as a COVID-19 monotherapy option with 150 patients, enrolled from nine leading government and private hospitals across the country.
So far, 30 patients have been randomised.Glenmark Pharmaceuticals is a global research-led company with presence across generics, speciality and OTC business with operations in over 50 countries. Its key therapy focus areas globally are respiratory, dermatology and oncology.
Glenmark Pharmaceuticals is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer; he named the company after his two sons.