Glenmark Pharmaceuticals on Friday announced that a combination of antiviral drugs Umifenovir and Favipiravir did not show any superior outcome in treating coronavirus disease (Covid-19) patients hospitalised with moderate symptoms during clinical trials.
“…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,” said Monika Tandon, senior vice president and head, clinical development, global specialty, branded portfolio, Glenmark.
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In May, the company had received approval from India’s drug regulator, the drugs controller general of India (DCGI), to conduct phase 3 clinical trials in the country using a combination of antiviral drugs Favipiravir and Umifenovir as a potential Covid-19 treatment strategy. The successful Favipiravir monotherapy trial earlier this year had led the company to receive ‘Emergency Use Authorisation’ for Favipiravir to treat Covid-19 patients.
The two antiviral drugs work differently. While Favipiravir is known to inhibit virus replication, thus killing the virus, Umifenovir does not allow the virus to enter the cell as it impedes the viral attachment to cells, therefore acting as a viral entry inhibitor, making it an ideal combination for effective tackling of high viral loads in patients during early stage of disease.
{{/usCountry}}The two antiviral drugs work differently. While Favipiravir is known to inhibit virus replication, thus killing the virus, Umifenovir does not allow the virus to enter the cell as it impedes the viral attachment to cells, therefore acting as a viral entry inhibitor, making it an ideal combination for effective tackling of high viral loads in patients during early stage of disease.
{{/usCountry}}“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,” said the company in a statement.
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The FAITH study enrolled a total of 158 hospitalised patients with moderate symptoms of Covid-19 in India.
The study’s primary end point (clinical outcome measured) was the time taken from randomisation to clinical cure, defined as the resolution of baseline clinical signs and symptoms of Covid-19 infection and at least a 2-point improvement on the 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,” the statement further read.
Favipiravir is an oral antiviral drug approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. Umifenovir is another oral antiviral drug licensed for the treatment and prophylaxis of influenza A and B infections in Russia and China. Additionally it exhibits modulatory effects on the immune system and induces interferon production.