Glenmark’s Favipiravir drug shows encouraging results in Phase 3 clinical trial

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Glenmark Pharmaceuticals a global research-led pharmaceutical company - on Thursday announced top-line results from a Phase 3 clinical trial in mild to moderate COVID-19 patients, conducted across seven clinical sites in India.

The open-label randomized, multicenter clinical trial, conducted in 150 patients, evaluated the efficacy and safety of Favipiravir plus standard supportive care (Favipiravir treatment arm), versus standard supportive care alone (control arm), in mild to moderate patients, randomized within a 48 hour window of testing RT-PCR positive for COVID-19.

The company said that patients randomised to Favipiravir treatment arm reported faster clinical cure and faster viral clearance than those randomized to the routine care group.

“Results from the Phase 3 trial showed numerical improvements for the primary efficacy endpoint with 28.6 per cent faster viral clearance in the overall population as measured by the median time until cessation of oral shedding of virus in the Favipiravir treatment arm compared to those in the control arm,” stated the company statement.

The study highlighted the efficacy and benefit of Favipiravir treatment arm over the control arm.

At least 40 per cent faster achievement of ‘clinical cure’ defined as the physician’s assessment of normalization of clinical signs - temperature, oxygen saturation, respiratory rate and cough with a statistically significant reduction in median time to clinical cure in the Favipiravir treatment arm (three days), compared to the control arm (five days).

About 69.8 per cent of patients in the Favipiravir treatment arm achieved clinical cure by Day 4, which was statistically significant compared to 44.9 per cent observed in the control arm.

“Amongst patients who clinically deteriorated and required oxygen support, those receiving Favipiravir had a longer median time to first-time use of oxygen of five days versus two days in the control arm.”

Methodology

The open-label randomized, multicenter clinical trial was conducted in 150 patients to evaluate the efficacy and safety of Favipiravir treatment arm versus standard supportive care alone (control arm), in mild to moderate patients, randomized within a 48-hour window of testing RT-PCR positive for Covid-19.

Patients received Favipiravir tablets 3,600 mg on day 1, followed by 800 mg twice daily to a maximum of 14 days, along with standard supportive care. Randomization was stratified based on disease severity into mild (90 patients) and moderate (60 patients).

(With inputs from ANI)