Merck today announced that their investigational oral antiviral drug molnupiravir significantly reduced the risk of hospitalisation or death in a Phase III trial in at risk patients with mild-to-moderate COVID.
Interim analysis showed that molnupiravir reduced the risk of hospitalisation or death by approximately 50%; 7.3% of patients randomised to receive molnupiravir were either hospitalised or died through Day 29 following randomisation, compared with 14.1% of placebo-treated patients. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. Study recruitment is being stopped early due to these positive results, and the company plans to submit an application for Emergency Use Authorisation (EUA) to the U.S. FDA as soon as possible.
Molnupiravir is an oral form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission.
All 775 patients had laboratory-confirmed mild-to-moderate COVID, with symptom onset within 5 days of study randomization and were required to have at least one risk factor associated with poor disease outcome at study entry. Across all key subgroups, molnupiravir reduced the risk of hospitalisation and/or death; efficacy was unaffected by timing of symptom onset or underlying risk factor. Additionally, based on the participants with available viral sequencing data (approximately 40% of participants), molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu.
The incidence of any adverse event was comparable in the molnupiravir and placebo groups, as was incidence of drug-related adverse events, and the drug was well tolerated.
In addition, molnupiravir is being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomised, double-blind, placebo-controlled Phase III study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID within households.
Source: Merck
