Glenmark gets DCGI approval for antiviral drug combo trial
NEW DELHI: Glenmark Pharmaceuticals on Tuesday said it received approval from the Drug Controller General of India (DCGI) to conduct phase three clinical trials in the country to test the efficacy of a combination of two antiviral drugs, Favipiravir and Umifenovir, as a potential coronavirus disease (Covid-19) treatment.
The two drugs act differently. Favipiravir is known to inhibit virus replication, thus killing the pathogen; Umifenovir impedes the viral attachment to cells,acting as a viral entry inhibitor.
The drugs make for an ideal combination in effectively tackling high viral loads in patients during early stage of disease.
Favipiravir is an oral antiviral drug approved in Japan in 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.
Additionally it exhibits modulatory effects on the immune system and induces production of interferons, natural proteins used to treat diseases that involve the immune system,.
“Hence a combined use of Favipiravir and Umifenovir acting on different mechanisms offers a comprehensive A antiviral cover on pre-entry and post-entry life-cycle of the SARS-CoV-2 virus. Early administration of a combination of antiviral medications acting by different mechanisms is recommended for the treatment of Covid-19, since the viral load of SARS-CoV-2, the virus that causes the disease, peaks around the time of symptom onset,” Glenmark Pharmaceuticals said in a statement.
“Combining antiviral drugs could result in greater clinical effectiveness and could also prevent, or delay, the emergence of resistance.”
“The current 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,” it added.
The trial will be a randomized, open-label study for which the company will soon start recruiting patients, with a target of enrolling about 158 patients.
“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 in medical professionals and healthcare workers by reducing the duration of virus shedding from treated patients,” said Monika Tandon, head, clinical development global specialty, Glenmark Pharmaceuticals.
About two weeks ago, Glenmark also received the Drug Controller General of India approvals for clinical trials on Favipiravi.
It aims to recruit around150 patients in nine government and private hospitals across the country, and has so far recruited 30.
The results for only Favipiravir Phase 3 clinical trial are expected by July/August 2020.
“We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful,” said Sujesh Vasudevan, president, India formulations, Middle East and Africa business, Glenmark.
THE TWO ANTIVIRAL DRUGS, FAVIPIRAVIR AND UMIFENOVIR, INHIBIT VIRAL REPLICATION AND IMPEDE THE ABILITY OF VIRUS TO ATTACH TO CELLS RESPECTIVELY