Merck announces that molnupiravir has reduced risk of death in a planned interim analysis of its Phase III trial

During day 29, there were no deaths in patients receiving mollupiravir, compared to 8 deaths in patients receiving placebo.

Merck recently announced that the oral antiviral drug mollupiravir significantly reduced the risk of hospitalization or death in a planned interim analysis of the Phase 3 MOVe-OUT trial.

In the interim analysis, molanupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients receiving molanupiravir were either hospitalized or died on day 29 after randomization (28/385), compared with 14.1 of placebo-treated patients (53/377). % Compared to; p = 0.0012.

During day 29, there were no deaths in patients receiving mollupiravir, compared to 8 deaths in patients receiving placebo. On the recommendation of an independent data monitoring committee and in consultation with the US Food and Drug Administration (FDA), these positive results have led to early termination of enrollment in the study.

Merck plans to submit an application for emergency use authorization (EUA) to the US FDA as soon as possible based on these findings. It also plans to submit marketing applications to other regulatory bodies around the world.

“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and profoundly impacting patients, families and societies and strains health care systems around the world. With these compelling results, we are hopeful that mollupiravir can become an important drug as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of pioneering infectious diseases when they are most needed. Will be In line with Merck’s unwavering commitment to saving and improving lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring mollupiravir to patients as quickly as possible,” said Robert M. Davis, Chief Executive said the officer and president, Merck.

“On behalf of all of us at Merck, I thank our network of clinical investigators and patients for their essential contribution to the development of molanupiravir,” he said.

“With the virus becoming more widely transmitted, and because currently available therapeutic options are infected and/or need access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of hospital Wendy Holman, chief executive officer of Ridgeback Biotherapeutics, said.

“We are very excited by the results of the interim analysis and hope that molnupiravir, if authorized for use, could have a profound impact in controlling the pandemic. Our partnership with Merck is critical to ensuring rapid global reach if this drug is approved, and we appreciate the collaborative effort to reach this critical stage of development.”

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