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Glenmark Pharmaceuticals said that a combination of antivirals umifenovir and favipiravir in the treatment of moderate hospitalised Covid-19 patients did not show significant clinical benefit.
Giving details on its ‘Faith’ trial with the two drugs, the company said: “the study showed no superior clinical outcomes with the addition of umifenovir (to the treatment with favipiravir).”
This was the second study undertaken by the drugmaker to evaluate the possible superiority of the combination’s efficacy against favipiravir monotherapy. The Faith study enrolled 158 hospitalised patients with moderate Covid-19 in India.
The first trial involving Favipiravir and done earlier this year had led to the company receiving an “Emergency Use Authorisation” on the drug.
Time taken for cure
The Faith trial’s primary endpoint (clinical outcome measured) was time taken from randomisation to clinical cure — defined as resolution of baseline clinical signs and symptoms of Covid-19 infection and at least a two-point improvement on the WHO Ordinal Scale for Clinical Improvement — within 28 days, the company said. Median time to clinical cure improved by only one day in patients who received the two-antiviral combination, which was not statistically significant and did not justify its use, they said.
Monika Tandon, Glenmark’s Senior Vice President & Head, Clinical Development (Global Specialty/Branded Portfolio) 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.”
In June 2020, Glenmark became the first company in India to receive manufacturing and marketing approval for FabiFlu® as part of accelerated approval process.
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