Announcing the results of its “FAITH” combination trials, the company said that addition of Umifenovir did not demonstrate any additional benefit over Favipiravir alone in moderate Covid-19 patients.
“Umifenovir did not show superior clinical outcomes when added to Favipiravir treatment. The trial did not meet key end-points,” it said in a statement.
This was the second clinical study after the 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 today presented to the regulator, the study showed no superior clinical outcomes with the addition of Umifenovir,” it further said.
The FAITH study enrolled a total of 158 hospitalized patients with moderate COVID-19 in India.
The Median time to clinical cure improved by only 1 day (7 as compared to 8) in patients who received the two antiviral combination. The company said it was not statistically significant and did not justify adding two antiviral agents.
Monika Tandon, Senior Vice President & 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 & effective choice for mild to moderate COVID-19 infection.”