Glenmark to study efficacy of two antiviral drugs for treating Covid-19
Glenmark Pharmaceuticals on Tuesday announced it has received approval from the Drugs Controller General of India (DCGI) to conduct phase 3 clinical trials for the efficacy of a combination of the antiviral drugs Favipiravir and Umifenovir as a potential treatment strategy for Covid-19.
The two drugs have different mechanisms of action – Favipiravir is known to inhibit virus replication, thus killing the virus, while Umifenovir doesn’t allow the virus to enter cells, as it impedes viral attachment and acts as a viral entry inhibitor. This results in an ideal combination for effectively tackling high viral loads in patients during the early stage of the disease.
Favipiravir is an oral antiviral drug approved in Japan since 2014 for treating novel or re-emerging influenza virus infections. Umifenovir is another oral antiviral drug licenced 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 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. 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 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…enhances antiviral efficacy on Covid-19 patients,” it said.
The trial will be a randomised, open-label study for which Glenmark will soon start recruiting about 158 patients.
Monika Tandon, head of Glenmark’s clinical development global specialty, 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 hope the combination therapy will reduce infection risk in medical professionals and healthcare workers by reducing the duration of virus shedding from treated patients.”
The new combination clinical trial will be called FAITH – (FA vipiravir plus Um I fenovir (efficacy and safety) Trial in Indian Hospital setting – and 158 hospitalised patients of moderate Covid-19 infection will be enrolled in the combination study and randomised in two groups.
One group will receive Favipiravir and Umifenovir (with standard supportive care), and another group will receive Favipiravir with standard supportive care.
Patients in the arm receiving the drug will receive Favipiravir 1800mg dose and Umifenovir 800 mg bid on Day 1. Thereafter patients will receive Favipiravir 800mg bid and Unifenovir 800mg bid for the remaining course of the treatment.
Duration of the 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 tests.
About two weeks ago, Glenmark received approvals for clinical trials on Favipiravir by the drugs controller. The firm aims to recruit 150 patients in nine government and private hospitals across the country for this, and has so far recruited 30 patients. The results for only Favipiravir phase 3 clinical trials are expected by July-August.
“We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful,” said Sujesh Vasudevan, Glenmark’s president for India formulations, Middle East and Africa business.