New Delhi: Glenmark Pharmaceuticals announced Tuesday that it will commence another new Phase 3 clinical trial. This will be on a combination of the two anti-viral drugs ‘Favipiravir’ and ‘Umifenovir’. The combination will be tried out in hospitalised patients affected by moderate COVID-19. Glenmark has received approval from the Indian regulator to initiate the study.
The combination study which will be called the ‘FAITH trial’ will look to enroll 158 hospitalised patients of moderate COVID-19. Early treatment with combination therapy will be evaluated for safety and efficacy. The combination is emerging as an effective approach in shortening duration of virus shedding. It is also decreasing cytokine response, and facilitating early discharge of patients.
Glenmark said the anti-virals with different mechanisms of action could complement and enhance efficacy against COVID-19. The company is still continuing its Phase 3 clinical trials on Favipiravir monotherapy for COVID-19 patients.
The company 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 anti-viral drugs have different mechanism of action, and their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during early stage of disease.
Early administration of a combination of anti-viral medications acting by different mechanisms is desirable for the treatment of COVID-19. This is because the viral load of SARS-CoV-2 peaks around the time of symptom onset. Thus combining anti-viral drugs could result in greater clinical effectiveness. It could also prevent, or delay, the emergence of resistance.
Favipiravir is an oral anti-viral 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. It 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 pre-entry and post-entry life-cycle of the SARS-CoV-2 virus.
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-19patients.
Agencies