The Mumbai-based drug company Glenmark Pharmaceuticals is set to commence phase 3 clinical trial to test the combined efficacy of antiviral drugs favipiravir and umifenovir as a potential COVID-19 treatment strategy.
The company announced that the new randomised, open-label study named FAITH – (Favipiravir plus Umifenovir (efficacy & safety) Trial in Indian Hospital setting) would enroll a total of 158 hospitalised patients suffering from moderate COVID-9 infection.
Favipiravir is an oral antiviral with a unique activity against RNA viruses. Upon intake, the drug is converted to the ribofuranosyl triphosphate derivative by host enzymes which selectively inhibit the influenza viral RNA-dependent RNA polymerase enzyme necessary for their replication.
Umifenovir is also an oral antiviral medication that is used in the treatment and prophylaxis of influenza A and B infections. The drug impedes viral attachment to cells and acts as a viral entry inhibitor. Additionally, it exhibits modulatory effects on the immune system and induces interferon-production.
Since the two antivirals act via different mechanism the researchers anticipate that their combination may demonstrate improved treatment efficacy during pre-entry and post-entry life-cycle of the SARS-CoV2 virus.
The pharma said that both antivirals inhibited virus infection in vitro and have shown efficacy in COVID-19 clinical trials. The current Glenmark study will examine whether early administration of this combination, both acting by different mechanisms, enhances antiviral efficacy on COVID-19 patients. The combinational drug therapy is expected to reduce the duration of virus shedding from treated patients.
In the meantime, the company is also involved in conducting phase 3 clinical trials testing the efficacy of favipiravir as a COVID-19 monotherapy option.