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At present, the new crown pneumonia epidemic abroad is still spreading rapidly.
Recently, Merck & Co and Ridgeback Biotherapeutics jointly announced the latest status of the clinical project of the oral antiviral drug molnupiravir (MK-4482/EIDD-2801).
Based on 2 ongoing evaluations of molnupiravir (2 times daily for 5 days) in the treatment of COVID-19 outpatients and COVID-19 inpatients in a placebo-controlled phase 2/3 clinical trial (MOVe-OUT, MOVe-IN) According to the planned interim data analysis of the Phase 2 dose discovery part (Part 1), and based on the data analysis of the phase 2a dose range study for outpatients previously completed, the two parties decided to continue the MOVe-OUT study in outpatients with COVID-19 In the Phase 3 part (Part 2), molnupiravir was evaluated at a dose of 800 mg orally twice a day.
Dr.
Ridgeback CEO Wendy Holman said: "We are pleased that molnupiravir continues to show promise as a potential treatment for COVID-19 ambulatory patients.
The chemical structure of molnupiravir (picture source: scinexx.
MOVe-OUT (MK-4482-002) and MOVe-IN (MK-4482-001) research update:
MOVe-OUT is an ongoing phase 2/3, randomized, placebo-controlled, double-blind, multi-site study to evaluate the efficacy of oral molnupiravir on COVID-19 non-hospitalized patients confirmed by polymerase chain reaction (PCR).
The first part of the MOVe-OUT study recruited 302 subjects.
In the MOVe-OUT study, among the 299 patients who received at least one dose of the study intervention, 6.
The External Data Monitoring Committee noted that the subgroup analysis supports the potential benefits of treatment, and suggested that the MOVe-OUT protocol be revised to focus on patients in the early stages of the disease course and those who are considered to have a high risk of adverse COVID-19 results Patients (for example, elderly patients, obese patients, and diabetic patients).
The final data of the MOVe-OUT study Phase 3 (Part 2) is expected to be available in September/October 2021.
Original source: 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