Study results showed that a lower proportion of participants treated with LAGEVRIO had an acute care visit compared with those who received the placebo.
Merck and Ridgeback Biotherapeutics announced additional data from the phase 3 MOVe-OUT data published in the Annals of Internal Medicine evaluating molnupiravir (Lagevrio), an investigational oral antiviral medicine, in non-hospitalized adults with mild to moderate COVID-19 who were at high risk for progressing to severe disease.
“The primary data from MOVe-OUT demonstrated a significant reduction in the risk for progression to severe COVID-19, including hospitalization and death, when compared to placebo among non-hospitalized, at-risk patients. In light of the continued burden of COVID-19, we are encouraged by these new data,” Wendy Holman, CEO of Ridgeback Biotherapeutics, said in a statement.
“We look forward to continuing to study [molnupiravir] with the goal of helping high-risk patients and overburdened healthcare systems globally continue to combat the COVID-19 pandemic,” she said.
Analyses of pre-specified exploratory endpoints indicated that a lower proportion of individuals treated with molnupiravir in the modified intent-to-treat population had an acute care visit or a COVID-19 related acute care visit at 7.2% compared with 10.6% for the placebo in the modified intent-to-treat population through day 29, with a relative risk reduction (RRR) of 32.1%.
Additionally, 6.6% of individuals who received molnupiravir reported a COVID-19-related acute care visit compared with 10% of the individuals receiving the placebo, with a RRR of 33.8%.
The modified intent-to-treat population included all individuals who were randomly assigned, received at least 1 dose of the study drug, and were not hospitalized before the first dose of the study drug.
Based on a post-hoc analysis, fewer individuals treated with molnupiravir in the modified intent-to-treat population required respiratory interventions, including conventional oxygen therapy, a high-flow heated and humidified device, invasive mechanical ventilation, or noninvasive mechanical ventilation compared with those treated with the placebo, with a RRR of 34.3% for all respiratory interventions.
Further, individuals in the safety population who received molnupiravir showed earlier and larger reductions in mean C-reactive protein values and earlier and larger improvements in mean change from baseline oxygen saturation values compared with individuals who received the placebo.
The safety population consisted of all individuals who had undergone randomization and had received at least 1 dose of molnupiravir.
The analyses also suggest that among the subgroup of individuals who were hospitalized after randomization in MOVe-OUT, the median time to hospital discharge was 9 days for individuals who received molnupiravir compared with 12 days in the placebo arm.
Consistent with the full modified intent-to-treat population data, the findings suggest that fewer individuals treated with molnupiravir who were hospitalized after randomization required respiratory interventions compared with individuals who received the placebo, with a RRR of 21.3% for all respiratory interventions.
In addition to this trial, molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a double-blind, global, multicenter, phase 3, placebo-controlled, randomized, study and evaluated the efficacity and safety of molnupiravir in preventing the spread of COVID-19 within households.
Merck and Ridgeback announce new data for investigational Lagervrio (molnupiravir) from phase 3 MOVe-OUT study. Merck. News release. June 7, 2022. Accessed June 9, 2022. https://www.merck.com/news/merck-and-ridgeback-announce-new-data-for-investigational-lagevrio-molnupiravir-from-phase-3-move-out-study/