Merck's Molnupiravir Fails to Meet Primary Endpoint in Phase III MOVe-AHEAD Trial for Post-Exposure Prophylaxis of COVID-19

On February 21, MSD announced that the Phase III MOVe-AHEAD study of molnupiravir for post-exposure prophylaxis of COVID-19 failed to meet its primary endpoint, meaning molnupiravir did not significantly reduce the risk of infection in participants exposed to COVID-19 through household contact in a statistically meaningful way. MSD stated that it will present or publish the full results of this study at a scientific conference.

Molnupiravir is the world's first approved oral antiviral drug for COVID-19. In December 2022, the drug received emergency conditional approval from the National Medical Products Administration of China for the treatment of adult patients with mild to moderate Coronavirus Disease 2019 (COVID-19) who are at high risk of progressing to severe disease.

In September 2022, MSD reached a cooperation with Sinopharm Group, granting Sinopharm the distribution rights and exclusive import rights of Molnupiravir within China. MSD revealed that it has already shipped more than one million courses of Molnupiravir to China and plans to increase the shipment volume.

MOVe-AHEAD (NCT04939428) is a randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of molnupiravir compared to placebo in preventing household transmission of COVID-19.

The MOVe-AHEAD study enrolled 1,539 adult participants who lived in the same household with someone testing positive for the coronavirus and had at least one sign or symptom of COVID-19, provided these signs and symptoms did not exceed 5 days. Participants were ineligible if they had received their first dose of a COVID-19 vaccine more than 7 days prior to enrollment, had previously been diagnosed with COVID-19, or exhibited any signs or symptoms of COVID-19. In the study, participants were randomly assigned to receive either 800 mg of molnupiravir or a placebo orally every 12 hours for 5 days.

The primary endpoints of this study include: the percentage of participants with COVID-19 (laboratory-confirmed SARS-CoV-2 infection, symptomatic) by Day 14, the percentage of participants experiencing adverse events, and the percentage of participants discontinuing study intervention due to adverse events.

Results showed that, compared with placebo, treatment with molnupiravir reduced the risk of COVID-19 infection (positive SARS-CoV-2 test post-baseline with symptoms and signs) by 23.6% in participants. However, this was not statistically significant and did not meet the primary endpoint. The safety profile of molnupiravir in this study was consistent with that observed in previous trials.

"As we continue to deepen our understanding of COVID-19, the results of this post-exposure prophylaxis study present an interesting scientific perspective. We thank the participants and researchers of the MOVe-AHEAD study for their contributions to this research," said Dr. Dean Y. Li, President of Merck Research Laboratories. "This is not a therapeutic study, and these results do not affect the efficacy and safety observed with molnupiravir in the Phase III MOVe-OUT study for the treatment of mild to moderate COVID-19. We remain committed to providing molnupiravir as a treatment option for appropriate high-risk patients with COVID-19 and further exploring how it may benefit patients with other infectious diseases, such as RSV."

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