Glenmark Pharma announced on October 9 that the addition of Umifenovir did not demonstrate any additional benefit over Favipiravir alone in moderate COVID-19 patients.

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It said no significant clinical benefit was seen with the addition of Umifenovir in COVID-19 treatment, as per the Glenmark clinical study. The addition of Umifenovir did not demonstrate any additional benefit over Favipiravir alone in moderate COVID-19 patients, it added. Umifenovir did not show superior clinical outcomes when added to Favipiravir treatment and the trial did not meet the key end-points. Glenmark on October 9 announced the results of its "FAITH" combination trial with antivirals Umifenovir and Favipiravir for the treatment of moderate hospitalised COVID-19 patients.

This was the second clinical study after the successful Favipiravir monotherapy trial earlier this year that led the company to receiving the emergency use authorisation for Favipiravir. This second study titled the FAITH trial evaluated the possible superiority of the combination's efficacy against Favipiravir monotherapy. As per the results that Glenmark presented to the regulator on October 9, the study showed no superior clinical outcomes with the addition of Umifenovir. The FAITH study enrolled 158 hospitalised patients with moderate COVID-19 in India.

The study's primary end point (clinical outcome measured) was the time taken from randomisation to clinical cure, defined as resolution of baseline clinical signs and symptoms of COVID-19 infection and at least 2-point improvement on WHO Ordinal Scale for Clinical Improvement, within a time frame of 28 days. Median time to clinical cure improved by only 1 day (7 as compared to 8) in patients who received the two antiviral combination, which was not statistically significant and did not justify adding two antiviral agents.

Commenting on the trial's findings, the Senior Vice President and Head, Clinical Development, Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals Ltd., said, "Glenmark was the first company to provide patients an oral antiviral treatment for COVID-19 in India, and this combination study was yet another effort on our part to examine new treatment options to combat the health crisis. "These latest findings confirm that the addition of Umifenovir does not show any incremental benefit in clinical outcomes. Thus Favipiravir therapy along with supportive care remains a suitable and effective choice for mild to moderate COVID-19 infection."