Merck Plans to Seek Emergency Use Authorization for Investigational Oral Antiviral for Mild, Moderate COVID-19

The investigational oral antiviral molnupiravir reduced the risk of hospitalization or death by approximately 50% among patients with mild or moderate COVID-19, according to new data from Merck.

Based on the planned interim analysis of the phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients, a press release from Merck said the company plans to seek emergency use authorization (EUA) from the FDA as soon as possible. If authorized, molnupiravir could be the first oral antiviral medication for COVID-19.

Molnupiravir is an oral form of a potent ribonucleoside analog that inhibits replication of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. According to the press release, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants.

The MOVe-OUT trial was a global, phase 3, randomized, placebo-controlled, double-blind, multi-site study of patients with COVID-19 who were not hospitalized but who had at least 1 risk factor associated with poor disease outcomes, and symptom onset within 5 days prior to randomization. The primary efficacy objective is to evaluate the efficacy of molnupiravir compared to placebo as assessed by the percentage of participants who were hospitalized or died from the time of randomization through day 29.

At the interim analysis, researchers found that molnupiravir reduced the risk of hospitalization or death by approximately 50%. Further, 7.3% of patients who received the drug were either hospitalized or died through day 29 following randomization, compared with 14.1% of patients in the placebo arm. Through day 29, no deaths were reported in patients who received molnupiravir compared with 8 deaths in the placebo arm.

Based on these positive results, recruitment for the trial is being stopped early. This decision is at the recommendation of an independent data monitoring committee and was made in consultation with the FDA, according to the press release.

“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world,” said Robert M. Davis, chief executive officer and president of Merck, in the press release.

The planned interim analysis evaluated findings from 775 patients who were initially enrolled in the trial on or before August 5, 2021. At the time of the decision to stop recruitment, the trial was approaching full capacity of the phase 3 sample size of 1550 patients, with more than 90% of the intended sample size already enrolled.

The incidence of adverse events (AEs) was comparable across both the molnupiravir and placebo arms (35% and 40%, respectively). Similarly, the incidence of drug-related AEs was also comparable (12% and 11%, respectively). Fewer subjects discontinued the study due to an AE in the molnupiravir group (1.3%) compared with the placebo group (3.4%).

“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a health care facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” said Wendy Holman, CEO of Ridgeback Biotherapeutics, in the press release. “We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic.”

REFERENCE

Merck and Ridgeback’s investigational oral antiviral molnupiravir reduced the risk of hospitalization or death by approximately 50 percent compared to placebo for patients with mild or moderate COVID-19 in positive interim analysis of phase 3 study. News release. Merck; October 1, 2021. Accessed October 1, 2021. https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/