Glenmark to begin human trials of a combination drug for COVID-19 in India

A combination of two antiviral drugs will soon be on trial, to study its effectiveness against symptoms of COVID-19 in India. Glenmark Pharmaceuticals, an India-based pharma company, on 26 May said it will conduct clinical trials for the combination of the drugs favipiravir and umifenovir, after having received a green signal from the Drugs Controller General of India (DGCI).

As many as 158 hospitalised patients of the new coronavirus infection with mild to moderate symptoms will be part of this randomised, open-label research called FAITH study.

The company had earlier begun a study on the effectiveness of favipiravir alone as a monotherapy, which it announced is also moving into Phase 3 of trials, with as many as 150 patients enrolled from nine different government and private hospitals across the country.

The combination therapy, however, is being touted as a more effective approach in reducing the viral load, lowering cytokine response and helping patients recover early.

What are favipiravir and umifenovir?

What are favipiravir and umifenovir?

Favipiravir is an anti-influenza drug approved for use in Japan since 2014. It stops the flu virus from replicating in the body, by inhibiting RNA polymerase—an enzyme that is crucial to the growth of some viruses. Some studies and trials are now looking into the effectiveness of favipiravir as an inhibitor of RNA polymerase in SARS-CoV-2, which causes COVID-19.

Umifenovir, on the other hand, has been used prophylactically in the treatment of influenza types A and B in countries like China and Russia. Reportedly, it works by preventing the viruses from attaching to healthy cells.

The scientists at Glenmark have proposed that two drugs, with their different mechanisms to stop the virus from entering healthy cells and multiplying, may help to treat patients in the early stages of COVID-19 infection.

Glenmark's announcement of the combination trial comes a month after a Chinese group of researchers studying the effectiveness of lopinavir/ritonavir (LPV/r) and umifenovir (Arbidol) to treat COVID-19 found that it offered little benefit or relief to the patients. The randomised trial studying the efficacy of these drugs was performed on 86 patients, and found that patients did not respond positively to the respective monotherapies either. Lopinavir/ritonavir is a fixed-dose combination drug for the treatment and prevention of HIV/AIDS.

Earlier studies have also shown that umifenovir, when used in monotherapy (as a standalone), was not effective in treating COVID-19.