Home / Companies / News /  Strides Pharma set to start clinical trials on potential covid drug

Strides Pharma Science Ltd will soon start clinical trials on potential coronavirus drug favipiravir, it said on Thursday. This makes it the second Indian company to study the broad-spectrum antiviral drug’s use in treating the fatal respiratory disease after Glenmark Pharmaceuticals Ltd.

The development comes even as world over multiple existing drugs are being looked at for treatment of the novel coronavirus infection, including the anti-malarial hydroxychloroquine (HCQ), the anti-cancer combination of lopinavir and ritonavir, and Gilead’s patented drug remdesivir, which had earlier failed trials to cure ebola.

“We have the approval of the Drug Controller General of India (DCGI) to conduct human studies and we will start the studies soon," Strides Pharma founder and non-executive chairman Arun Kumar said during a post-earnings conference call.

Kumar, however, did not give details on the number of sites where the trial will be conducted or when it will start.

The Bengaluru-based pharmaceuticals firm had on 29 April said it will seek the approval of the Central Drugs Standard Control Organization (CDSCO), headed by V.G. Somani, to sell the generic version of favipiravir. The drugmaker has already developed and commercialized the antiviral tablets and will export it to three countries of the Gulf Cooperation Council.

Strides has developed favipiravir tablets in 400 mg and 200 mg strengths for convenient dosage administration.

Favipiravir was developed by Japan’s Toyama Chemical, which is part of the Fujifilm group, and sold under the name of Avigan. The drug was developed to treat influenza and went generic last year.

With no drugs showing results the world over, countries are developing their own protocols by giving emergency use authorizations to existing drugs that show potential. “Several countries are creating their own protocols for repurposed drugs. Many countries have taken HCQ off their protocols, but Brazil yesterday put HCQ as the primary treatment regimen. So, everybody is creating protocols based on science, or lack of it. At this time, we live in a world of ambiguity," Kumar said.

Glenmark started its own clinical trials earlier this month, enrolling about 150 patients with mild to moderate covid-19 in 10 hospitals for the randomized, open-label study. The company expects to complete the study by August.

Glenmark’s phase 3 trial began on Wednesday, according to the government’s clinical trial registry.

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