Glenmark Pharmaceuticals rose 3.17% to Rs 426.80 after the company announced top-line results from phase 3 clinical trial of favipiravir in patients with mild to moderate COVID-19.The drug maker on Wednesday 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) in mild to moderate patients, randomized within a 48 hour window of testing RT-PCR positive for COVID-19.
Patients in the Glenmark Favipiravir clinical trial received Favipiravir tablets 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days, along with standard supportive care. Randomization was stratified based on disease severity into mild (90 patients) and moderate (60 patients)
Results from the Phase 3 trial showed numerical improvements for the primary efficacy endpoint with 28.6% 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.
Additionally, the company said Favipiravir was well tolerated with no serious adverse events (SAEs) or deaths in the Favipiravir treated arm.
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.
On 20 June 2020, Glenmark announced that it received manufacturing and marketing approval from India's drug regulator for FabiFlu, making it the first oral approved medication in India for the treatment of mild to moderate COVID-19.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.
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