Merck Canada Initiates Rolling Submission to Health Canada for Molnupiravir, an Investigational Oral Antiviral for the Treatment of COVID-19

Currently, the overseas COVID-19 pandemic continues to spread rapidly. According to Baidu's "Real-time Big Data Report on the Novel Coronavirus Pneumonia Epidemic," as of 00:00 on August 17, 2021, global cumulative confirmed cases exceeded 208 million (208.27 million), and deaths exceeded 4.379 million.

Recently, MSD announced that it has initiated a rolling submission to Health Canada for molnupiravir (MK-4482/EIDD-2801). The drug is a twice-daily oral antiviral currently in clinical trials as a potential treatment for COVID-19.

Under Health Canada’s Interim Order, a rolling submission process is acceptable, allowing for the review of early safety, quality, and efficacy data while late-stage clinical trials are ongoing. Further results from the ongoing molnupiravir development program will be shared with Health Canada as they become available. It should be noted that Health Canada will only make an approval decision after all necessary evidence has been submitted and reviewed.

The Phase 2 interim results of the Phase 2/3 MOVe-OUT clinical trial were presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in July this year. Data showed that molnupiravir demonstrated the greatest efficacy in non-hospitalized COVID-19 patients with symptom onset <5 days. Phase 3 of the trial is currently ongoing, including at several clinical trial sites in Canada, where non-hospitalized adult patients diagnosed with SARS-CoV-2 infection who have at least one risk factor associated with poor disease outcomes are receiving molnupiravir twice daily for 5 days, initiated within 5 days of symptom onset.

Molnupiravir is a potent, orally administered ribonucleoside analog that inhibits the replication of various RNA viruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the pathogen responsible for COVID-19. Molnupiravir has demonstrated activity in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, and has also shown activity in preclinical models of SARS-CoV-1 and MERS.

MOVe-OUT (MK-4482-002; NCT04575597) is an ongoing Phase 2/3, randomized, placebo-controlled, double-blind, multicenter study evaluating the efficacy, safety, and pharmacokinetics of oral molnupiravir in non-hospitalized adult patients (aged ≥18 years) with laboratory-confirmed COVID-19 and symptom onset within 5 days prior to randomization.

The trial plans to enroll 1,850 patients with mild or moderate COVID-19. In the Phase 3 portion of the trial, 1,550 patients will be randomized in a 1:1 ratio to two groups to receive oral molnupiravir (800 mg) or placebo twice daily for 5 days. The primary efficacy objective is to evaluate the efficacy of molnupiravir versus placebo based on the percentage of patients hospitalized and/or who die from randomization through Day 29.

Original Source: Merck Canada Initiates Rolling Submission to Health Canada for Molnupiravir, an Investigational Oral Therapeutic Agent for the Treatment of COVID-19

Source: Bioon. For more information, please download the Bioon App (http://www.bioon.com/m/).