The MOVe-OUT study will continue to the phase 3 portion and evaluate 800 mg of the therapy administered twice daily.
Merck Pharmaceuticals and Ridgeback Biotherapeutics have announced that their investigational oral therapeutic for the treatment of mild-to-moderate COVID-19, molnupiravir, has showed promising results as part of their phase 2/3 trial.
Results from the trial were also recently presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
“We continue to make progress in the clinical development of our antiviral candidate molnupiravir. Data from the dose-finding portion of these studies are consistent with the mechanism of action and provide meaningful evidence for the antiviral potential of the 800 mg dose,” Roy Baynes, senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories said. “Based on the findings of this study we are advancing a Phase 3 trial program in non-hospitalized patients that strategically leverages our large network of clinical sites to enroll appropriate patients globally.”
The ongoing phase 2/3, randomized, placebo-controlled, double-blind, multi-site study is evaluating the efficacy, safety and pharmacokinetics of orally administered molnupiravir in non-hospitalized participants with a PCR confirmed case of COVID-19.
Part 1 of the trial included 302 participants who had symptom onset within 7 days prior to randomization and were assigned to receive either 200 mg, 400 mg or 800 mg of molnupiravir or a placebo.
Findings from part 1 of the trial demonstrated that the percentage of patients who were hospitalized and/or died was lower in the combined molnupiravir-treated groups versus the placebo arm.
Additionally, those participants who received 800 mg of the therapy had the largest overall antiviral effect, in comparison to those who received 200 mg or 400 mg.
Part 2 of the trial, the phase 3 portion, will evaluate an 800 mg dose of molnupiravir administered twice daily.
The companies estimated that data from the phase 3 portion will be available in September or October of 2021.
“We are pleased that molnupiravir continues to show promise as a potential treatment for non-hospitalized patients with COVID-19,” Wendy Holman, chief executive officer at Ridgeback Biotherapeutics said. “Data from Ridgeback Bio’s EIDD-2801-2003 study (MK-4482-006) coupled with Merck’s MK-4482-002 study provide compelling evidence for the antiviral activity of molnupiravir. We look forward to the initiation and completion of the Phase 3 portion of the MOVe-OUT study.”