Molnupiravir (new anti-viral): Interim Data

New oral anti-viral therapy to treat covid-19

The MOVe-OUT study was a global, Phase 3, randomized, placebo-controlled study., A planned interim analysis showed that molnupiravir reduced the risk of hospitalization or death by ~50% compared to placebo in those with mild/moderate Covid-19 with at least one risk factor that puts them at a higher risk for severe illness.

The analysis included results from 755 initially enrolled participants. 7.3% of molnupiravir-treated were either hospitalized or died through Day 29 whereas 14.1% of placebo-treated were either hospitalized or died through Day 29. This difference was statistically significant (p=0.0012). Efficacy was not affected by timing of symptom onset or underlying risk factor.

Through Day 29, no deaths were reported in those who received molnupiravir and there were 8 deaths in those who received placebo. Incidence of drug-related adverse events were comparable in the molnupiravir (12%) and placebo (11%) groups.

40% of participants had available viral sequencing data. Molnupiravir had consistent efficacy across variants Gamma, Delta, and Mu.

The study is being discontinued earlier than anticipated. Trials for new medications have a Data Safety Monitoring Board (DSMB)that continuously checks to ensure there are no critical issues on safety or efficacy that would necessitate halting the trial mid-way. This can either be done due to safety reasons, or due to futility (ie the drug is not efficacious) or due to the fact that the drug being assessed has much higher efficacy, making it unethical to continue to have a placebo group.

Remember that this is science by press release and full data has not been released yet. Next step: applying for authorization. Merck has indicated they will be appliying for EUA in the coming weeks, and also submitting to other global health regulators simultaneously.

One of the challenging concerns will be access – whether production can be scaled up quick enough, if we will see global equity in distribution, who will be able to access this drug, whether it be reimbursed, will people need to pay out of pocket and if so, who will be able to afford this, will special access be available and much more.