Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that data evaluating LAGEVRIO™ (molnupiravir), an investigational oral antiviral COVID-19 medicine, will be presented at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) (Abstract #4514).
The presentation includes final analyses evaluating virologic outcomes throughout and following a five-day course of LAGEVRIO as part of the Phase 3 MOVe-OUT trial, which studied LAGEVRIO versus placebo for the treatment of COVID-19 in non-hospitalized adults with mild to moderate COVID-19 who were at high risk for progressing to severe disease. Among study participants for whom samples were available, viral infectivity was assessed via a plaque-forming assay in Vero cells. Prespecified exploratory virologic outcomes included changes from baseline in SARS-CoV-2 RNA levels, and the percentage of study participants with viral clearance (i.e., undetectable SARS-CoV-2 RNA) and undetectable infectious SARS-CoV-2 through Day 29 in the modified intent-to-treat (mITT) population (≥1 dose of study intervention and not hospitalized prior to first dose).
In participants with infectious virus isolated at baseline and for whom post-baseline infectivity data were available, molnupiravir was associated with more rapid elimination of infectious virus than placebo. At Day 3 of treatment, among patients with infectious virus at baseline, infectious SARS-CoV-2 was detected in 0.0% (n=0/92) of patients who received LAGEVRIO, compared with 21.8% (n=20/96) of patients who received placebo. At Day 5, infectious virus was detected in 0.0% (n=0/91) of patients in the LAGEVRIO arm compared with 2.2% (n=2/89) in the placebo arm. At Day 10, no infectious virus was detected in either arm for patients with infectious virus at baseline. Molnupiravir was also associated with greater mean reductions from baseline in SARS-CoV-2 RNA than placebo from Days 3 through 10, though molnupiravir and placebo were associated with comparable rates of viral RNA clearance through Day 29.
“In these exploratory analyses from our Phase 3 study in patients with mild to moderate COVID-19, LAGEVRIO, an investigational oral antiviral medicine, cleared infectious SARS-CoV-2 faster than placebo among patients who had infectious virus at baseline, resulting in no infectious virus detected at Day 3, 5 or 10,” said Dr. Jay Grobler, associate vice president, infectious diseases and vaccines, Merck Research Laboratories. “These data reinforce our confidence in the potential of LAGEVRIO as a part of the solution to the COVID-19 pandemic.”
“We are encouraged by these data, which are consistent with findings from the Ridgeback Bio sponsored Phase 2 trial. These additional data will help to strengthen the base of scientific knowledge around LAGEVRIO as a treatment option for mild to moderate COVID-19 in appropriate patients,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. “We look forward to continuing to study LAGEVRIO to build our understanding with the goal of helping high-risk patients around the world.”
Additional molnupiravir data to be presented at ECCMID include:
– Abstract #4865: Effects of Molnupiravir on the SARS-CoV-2 Genome: Next-Generation Sequencing Data from the MOVe-OUT Phase 3 Trial. J. Strizki.
– Abstract #4545: Molnupiravir for the Treatment of COVID-19 in Immunocompromised Patients: Efficacy, Safety, and Virology Results from the Phase 3 MOVe-OUT Trial. M. Johnson.
– Abstract #4548: Impact of Molnupiravir Treatment on Patient-Reported COVID-19 Symptoms in the MOVe-OUT Study. Y. Guan.
– Abstract #5113: Cost-effectiveness analysis of molnupiravir versus best supportive care for the outpatient treatment of adults with COVID-19. H. Goswami.
In addition to the MOVe-OUT trial, molnupiravir is 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.
In the U.S. and select markets outside the U.S., LAGEVRIO is the approved trademark for molnupiravir.