Glenmark Announces Top-Line Results From Phase 3 Clinical Trial of Favipiravir in Patients With Mild to Moderate COVID-19
Phase 3 Trial Demonstrates Statistically Significant Faster Time to Clinical Improvement with Favipiravir Treatment in Mild to Moderate COVID 19 Patients Compared to Control
MUMBAI, India,?July 22, 2020?/PRNewswire/ -- Glenmark Pharmaceuticals Ltd. - a global research-led pharmaceutical company - today 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. 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. 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 (Hazard Ratio 1.367 [95%CI 0.944,1.979]; p=0.129). Key secondary outcome measures for clinical improvement demonstrated the efficacy and benefit of Favipiravir treatment arm over the control arm:- 40% 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 (3 days [95%CI 3.0, 4.0]), compared to the control arm (5 days [95%CI 4.0,6.0]) (HR 1.749 [95% CI 1.096, 2.792]; p=0.029).
- 69.8% of patients in the Favipiravir treatment arm achieved clinical cure by Day 4, which was statistically significant compared to 44.9% observed in the control arm (p=0.019).
- Amongst 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 (95%CI 1.0,6.0) versus 2 days (95% CI 1.0-4.0) in the control arm.
Glenmark Pharmaceuticals Ltd. (GPL) 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. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). For more information, visit?www.glenmarkpharma.com Logo:?http://mma.prnewswire.com/media/451507/PRNE_Glenmark_Logo.jpg