Results of an interim analysis for the Phase 3 trial of molnupiravir, an investigational oral antiviral for COVID-19 produced by Merck and Ridgeback Biotherapeutics, showed the drug capable of cutting hospitalization or death risk approximately in half.
For the purposes of the trial, over the course of 29 days, a randomized, placebo-controlled study of non-hospitalized patients with confirmed cases of COVID-19 was conducted at more than 170 planned sites all over the world. However, this interim analysis evaluated data specifically from the 775 patients enrolled in the trial prior to Aug. 5, 2021.
Of these patients, 7.3 percent (28 people) of those given molnupiravir were hospitalized at some point over those 29 days. Comparatively, 14.1 percent — 53 people — of those given placebos were either hospitalized or died. No one given molnupiravir died. A total of eight deaths were reported over the course of the trial. Importantly, molnupiravir was also successful in its task across all key subgroups of patients and proved consistently effective against variant strains, including Gamma, Delta and Mu.
“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,” Robert Davis, CEO and president of Merck, said. “With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most.”
Consequently, Merck pledged to seek Emergency Use Authorization from the U.S. Food and Drug Administration (FDA), and other regulatory agencies worldwide, as soon as possible. If approved, molnupiravir would become the first oral antiviral medicine for COVID-19. Given its success in trial, the Phase 3 trial was stopped early, on the recommendation of an independent Data Monitoring Committee.
“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,” Wendy Holman, CEO of Ridgeback Biotherapeutics, said. “Our partnership with Merck is critical to ensuring rapid global access if this medicine is approved, and we appreciate the collaborative effort to reach this important stage of development.”