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 4

About the MOVe-IN study design

MOVe-IN (MK-4482-001) was a Phase 2/3, randomized, placebo-controlled, double-blind, multi-site trial evaluating the efficacy, safety, and pharmacokinetics of orally administered molnupiravir in hospitalized participants at least 18 years of age with laboratory confirmed COVID-19 and symptom onset within 10 days prior to randomization. The Phase 2 portion of the trial enrolled 304 participants randomized 1:1:1:1 to who received molnupiravir 200 mg, 400 mg, 800 mg or placebo twice daily for 5 days. The primary efficacy endpoint was to evaluate the efficacy of molnupiravir compared to placebo as assessed by the rate of sustained recovery from randomization through Day 29. Exploratory endpoints supporting dose selection for the Phase 3 portion (Part 2) of the trial included change from baseline in SARS-CoV-2 RNA levels and percentage of participants with undetectable SARS-CoV-2 RNA at various time points, viral RNA mutation rate as assessed by comparison of baseline and post-baseline virus sequencing and pharmacokinetic data (eg, Ctrough, Cmax, tmax, t1/2, AUC0-12). Following an interim analysis of data, it was concluded that the study was unlikely to demonstrate a clinical benefit in hospitalized patients. The decision was made to discontinue the study.

About Molnupiravir Protocol MK-4482-006 (also known as EIDD-2801-2003)

Protocol 6 (MK-4482-006) is a Phase 2a, double-blind, placebo-controlled, randomized trial designed to compare the safety, tolerability, and antiviral activity of molnupiravir versus placebo as measured by viral RNA detection in symptomatic, outpatient (at baseline) adults at least 18 years old with SARS-CoV-2 infection as confirmed by viral RNA detection within seven days of symptom onset. Of 202 treated participants, molnupiravir was considered generally well tolerated and of the 4 serious adverse events reported, none were considered study drug related. Preliminary data from this study was previously presented at CROI 2021.

About Molnupiravir Nonclinical studies

Merck has conducted a comprehensive nonclinical program to characterize the safety profile of molnupiravir. This program included assays such as Big Blue and PIG-a which are designed to provide a robust measure of a drug or chemical’s ability to induce mutations in vivo. Animals were administered molnupiravir for longer and at higher doses (mg/Kg) than those employed in human studies. The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems.