The results also demonstrated 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, it added.
Glenmark Pharmaceuticals on Wednesday said Phase 3 clinical trial of antiviral drug Favipiravir in mild to moderate COVID-19 patients demonstrated significant faster time to clinical improvement.
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 in the Favipiravir plus standard supportive care compared to those in the standard supportive care alone (control arm) , Glenmark said in a statement.
The results also demonstrated 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, it added.
“69.8 per cent of patients in the Favipiravir plus standard supportive care (Favipiravir treatment arm) achieved clinical cure by Day 4, which was statistically significant compared to 44.9 per cent observed in the control arm,” the statement said.
Among patients who clinically deteriorated and required oxygen support, those receiving Favipiravir had a longer median time to first time use of oxygen of 5 days versus 2 days in the control arm, it added.
Glenmark’s Favipiravir was well tolerated with no serious adverse events or deaths in the Favipiravir treated arm. Adverse events were reported in 26 patients in the Favipiravir treatment arm as compared to six patients in the control arm, it added.
However, most adverse events were mild to moderate and none led to drug discontinuation or dosing adjustments, the statement said.
“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 ARDS and mortality,” Glenmark Vice President & Head – Clinical Development, Global Specialty/Branded Portfolio Monika Tandon said.
On June 20, the company had announced receiving manufacturing and marketing approval from India’s drug regulator for Favipiravir for the treatment of mild to moderate COVID-19. The company sells the drug under the brand name FabiFlu at a price of Rs 75 per tablet.
Shares of Glenmark Pharmaceuticals settled at Rs 413.70 per scrip on BSE, down 0.13 per cent from its previous close.