If authorised, molnupiravir could be the first oral antiviral medicine for Covid-19.
Merck (known as MSD outside the United States and Canada) and Ridgeback Biotherapeutics have announced that molnupiravir, an investigational oral antiviral medicine, significantly reduced the risk of hospitalisation or death at a planned interim analysis of the Phase III MOVe-OUT trial in at risk, non-hospitalised adult patients with mild-to-moderate Covid-19.
At the interim analysis, molnupiravir reduced the risk of hospitalisation or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalised or died, compared with 14.1% of placebo-treated patients by 29 days. After this time, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received the placebo.
At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.
“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. 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. Consistent with Merck’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible,” said Robert M. Davis, chief executive officer and president, Merck. “On behalf of all of us at Merck, I thank our network of clinical investigators and patients for their essential contributions to the development of molnupiravir.”
“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare 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, chief executive officer of Ridgeback Biotherapeutics. “We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorised for use, can make a profound impact in controlling the pandemic. 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.”