Update on phase III MOVe-AHEAD trial evaluating Lagevrio for post-exposure prophylaxis for prevention of COVID-19
Merck Inc., known as MSD outside the United States and Canada, announced that Lagevrio (molnupiravir) did not demonstrate a statistically significant reduction in the risk of COVID-19 following household exposure to another individual with COVID-19
The Phase III MOVe-AHEAD trial evaluated people who did not have COVID-19 at baseline (confirmed by a negative baseline SARS-CoV-2 test and no signs and symptoms) but lived with someone who was recently diagnosed with COVID-19. In the primary endpoint of participants who did not have evidence of SARS-CoV-2 infection at baseline (confirmed by a negative SARS-CoV-2 test), the Lagevrio treated group was observed to be 23.6% less likely than those who received placebo to develop COVID-19 through Day 14 (a positive post-baseline SARS-CoV-2 test with evidence of signs and symptoms); the primary endpoint was not met. The safety profile of Lagevrio in this trial was generally consistent with that observed in previously reported clinical studies and post-authorization experience in the treatment of COVID-19. Merck intends to submit full results from this study for presentation at a sci entific meeting or for publication.
Dr. Dean Y. Li, president, Merck Research Laboratories said “This was not a treatment study and these results do not impact the efficacy and safety data observed in our Phase III MOVe-OUT trial for the treatment of mild-to-moderate COVID-19. We remain focused on our ongoing efforts to bring Lagevrio as treatment to appropriate high-risk patients with COVID-19 where its use is authorized or approved, as well as to further study the ways it may benefit patients with other infectious diseases, such as RSV.”