Oral Antiviral Reduced COVID-19 Hospitalization or Death Risk by About 50%

New Jersey-based Merck and Ridgeback Biotherapeutics today announced that molnupiravir, an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19.

At the interim study analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%.

Furthermore, 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012.

Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received 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 apply 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.

“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,” stated Wendy Holman, CEO of Miami, FL based Ridgeback Biotherapeutics, in a press release.

In anticipation of the results from the MOVe-OUT clinical study, Merck has been producing molnupiravir at risk.

Merck expects to produce 10 million courses of treatment by the end of 2021.

Earlier in 2021, Merck entered into a procurement agreement with the U.S. Government. As a result, Merck will supply approximately 1.7 million courses of molnupiravir to the U.S. government upon EUA or FDA Approval. 

Additionally, Merck has entered into supply and purchase agreements for molnupiravir with other governments, pending regulatory authorization, and is currently in discussions with other governments.

As of October 1, 2021, molnupiravir is under review by Canada, the U.K., and European Medicines Agency.

Merck is committed to providing timely access to molnupiravir globally, if authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.

As part of its commitment to widespread global access, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate the availability of molnupiravir in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.

Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of the SARS-CoV-2 betacoronavirus, the causative agent of COVID-19. 

Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households.

The development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and Merck & Co., Inc. All equity capital in Ridgeback Biotherapeutics, L.P. originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. 

For more information, please visit http://merckcovidresearch.com.