Covid-19 treatment: Glenmark’s phase-3 clinical trial of Favipiravir shows positive response

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Updated: Jul 23, 2020 7:43 AM

Favipiravir is a broad spectrum oral antiviral drug that selectively inhibits RNA-dependent RNA polymerase (RdRp) and the viral replication phase of SARS-CoV-2, and is being studied in multiple ongoing international clinical trials.

The company plans to submit the clinical trial data for publication in a peer-reviewed journal in the coming weeks.The company plans to submit the clinical trial data for publication in a peer-reviewed journal in the coming weeks. (Representative image)

Glenmark Pharmaceuticals has said that its phase-3 clinical trial of Favirpiravir on mild-to-moderate Covid-19 patients showed a 28.6% faster viral clearance among those treated with the anti-viral drug than those who were on standard therapy. Besides, there was a 40% faster achievement of clinical cure which is defined as the physician’s assessment of normalisation of clinical signs such as temperature, oxygen saturation, respiratory rate and cough. The company plans to submit the clinical trial data for publication in a peer-reviewed journal in the coming weeks.

Announcing its top-line results from a phase-3 clinical trial conducted across seven clinical sites in India, the company said that the open-label randomised, multicenter clinical trial, conducted in 150 patients, evaluated the efficacy and safety of Favipiravir along with standard supportive care versus standard supportive care alone in mild-to-moderate patients, randomised within a 48-hour window of testing RT-PCR positive for Covid-19.

Favipiravir is a broad spectrum oral antiviral drug that selectively inhibits RNA-dependent RNA polymerase (RdRp) and the viral replication phase of SARS-CoV-2, and is being studied in multiple ongoing international clinical trials. Glenmark received manufacturing and marketing approval from drug regulator for FabiFlu, making it the first oral approved medication in India for the treatment of mild-to-moderate Covid-19. The company commenced a post-marketing surveillance (PMS) study on FabiFlu to closely monitor the efficacy and safety of the drug in 1,000 patients that are prescribed with the oral antiviral, as part of an open label, multicenter, single arm study.

“The results of the Indian Favipiravir study are encouraging. The trial was performed with a sense of urgency considering the gravity of the pandemic, yet scientific principles were not sacrificed. I have had a chance to independently view the initial results and they are encouraging. Patients randomised to Favipiravir seemed to have faster clinical cure, and more importantly, faster viral clearance than those randomized to the routine care group. I eagerly await the final analysis and results from other ongoing studies from across the globe. Till then, I feel we have enough evidence to consider using Favipiravir in symptomatic Covid-19 patients who have mild to moderate infection,” Dr Zarir Udwadia, one of the Principal Investigators of this study, said in a statement.

“We are encouraged with the top-line results and these indicate that early treatment with favipiravir may improve clinical outcomes for mild to moderate patients and could potentially prevent patients from progressing to acute respiratory distress syndrome and mortality,” Dr Monika Tandon, Vice President & Head – Clinical Development, Global Specialty/Branded Portfolio said.

The company said that Favipiravir was well tolerated with no serious adverse events (SAEs) or deaths in the Favipiravir treated arm. “One SAE occurred in the control arm and resulted in death due to worsening clinical disease and acute respiratory distress syndrome (ARDS) attributed to Covid-19 infection. Adverse events (AEs) were reported in 26 patients in the favipiravir treatment arm (35.6%) as compared to six patients in the control arm (8%) however, most AEs were mild to moderate and none led to drug discontinuation or dosing adjustments. Gastrointestinal disturbance was minimal and no clinically significant differences were observed between the treatment groups,’’ the company said.

Meanwhile, the company is also conducting another phase 3 clinical trial in India to evaluate the efficacy of two antiviral drugs Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult Covid-19 patients. The combination study, which is called the FAITH trial, is looking to enroll 158 hospitalised patients of moderate Covid-19.

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