Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19 - Seite 2

The percentage of patients who were hospitalized and/or died in Part 1 of the MOVe-OUT study was lower in the combined molnupiravir-treated groups versus the placebo arm; the number of events reported are not sufficient to provide a meaningful measure of clinical effect. Analysis of SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs from patients in both MOVe-OUT and MOVe-IN using quantitative and qualitative polymerase chain reaction, an exploratory endpoint, indicated that molnupiravir inhibits replication of the virus, as demonstrated by a greater decrease from baseline in viral RNA compared to placebo at Day 5 and Day 10, and by a larger proportion of participants with undetectable viral RNA at Day 10 and Day 15 following the end of treatment. The largest overall magnitude of antiviral effect was observed in the 800 mg dose compared with the 200 mg and 400 mg doses. These differences in virology endpoints were more pronounced in participants enrolled < 5 days following symptom onset.

Among 299 patients who received at least one dose of study intervention in MOVe-OUT, 6.2% (14/225) of those receiving molnupiravir and 6.8% (5/74) of those receiving placebo reported drug-related adverse events. In MOVe-IN, of 293 patients who received at least one dose of study intervention, 11.0% (24/218) of those treated with molnupiravir and 21.3% (16/75) of those receiving placebo reported drug-related adverse events. To date, safety and laboratory data from MOVe-IN and MOVe-OUT provide no evidence for unexpected findings or trends observed at any of the doses studied. In both trials, no deaths were considered drug-related by the investigators, and there were no drug-related adverse events that led to discontinuation in participants who received molnupiravir. Interim results from both MOVe-IN and MOVe-OUT, including virology findings and pharmacokinetic analyses, have been shared with regulatory authorities and will be presented at an upcoming medical meeting.

The external Data Monitoring Committee noted that the subgroup analyses support potential benefit of treatment and suggested amendments to the MOVe-OUT protocol to focus enrollment on patients early in the course of disease and those considered high risk for poor COVID-19 outcomes (e.g., older patients, those with obesity and diabetes). Based upon these recommendations, Merck will amend the inclusion criteria for MOVe-OUT by reducing the allowable symptom duration for enrollment to < 5 days and by enrolling participants with at least one risk factor for progression to severe disease. Merck plans to start enrolling patients in Phase 3 portion (Part 2) of MOVe-OUT by late April/early May.