Glenmark Pharmaceutical’s Antiviral Drug Hits the Mark in Small, Phase III COVID-19 Study
An antiviral drug developed by Glenmark Pharmaceuticals boosted the time it takes COVID-19 patients with mild to moderate symptoms to improve their health in a Phase III study.
On Wednesday, Glenmark announced Phase III results that showed its antiviral treatment favipiravir demonstrated a 28.6% faster viral clearance of COVID-19 compared to placebo. 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. The drug is marketed as FabiFlu in India, where it has already been approved for use against COVID-19. Favipiravir was granted approval in Russia for the treatment of COVID-19 in May and is being assessed in multiple ongoing international clinical trials.
The Phase III study, conducted in 150 patients in India, assessed favipiravir plus standard supportive care versus standard supportive care alone, in mild to moderate patients, randomized within a 48-hour window of testing RT-PCR positive for COVID-19.
In addition to the faster viral clearance of COVID-19, favipiravir also hit a number of key secondary endpoints, including a 40% faster achievement of “clinical cure.” That is defined as the physician’s assessment of normalization of clinical signs such as temperature, oxygen saturation, respiratory rate and cough. Favipiravir showed a statistically significant reduction in median time to clinical cure compared to placebo, Glenmark said. Additionally, Glenmark said 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. Among 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 compared to two days for placebo.
Favipiravir was well tolerated in the study, with no serious adverse events, Glenmark said.
Cynthia Caracta, vice president of Clinical Sciences and Global Respiratory Specialty and Innovative Medicines at Glenmark U.S., said the results of the favipiravir study are very encouraging in the midst of the COVID-19 pandemic.
“For the patients in the Glenmark favipiravir trial, there appears to be faster clinical improvement, two days earlier than standard care alone. Given these results, we believe Glenmark’s favipiravir may prove beneficial to mild to moderate patients with COVID-19 globally,” Caracta said in a statement.
Glenmark intends to submit the data for publication in a peer-reviewed journal. The company did not mention plans to seek approval from the U.S. Food and Drug Administration for COVID-19.
Glenmark is also conducting another Phase III 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.