The oral antiviral molnupiravir from Merck (NYSE:MRK) and Ridgeback Biotherapeutics fared well in a planned interim analysis of the Phase 3 MOVe-OUT trial.
If authorized by FDA, the pill would be the first oral antiviral for SARS-CoV-2 in the U.S.
To date, all authorized or approved COVID-19 drugs require subcutaneous, intramuscular or intravenous administration.
Merck intends to file an EUA for the oral therapy soon.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most,” Merck CEO Robert M. Davis said in a statement.
The molnupiravir study focused on initially non-hospitalized adults with mild-to-moderate COVID-19. It found that 7.3% of molnupiravir recipients were hospitalized within 29 days. By contrast, 14.1% of placebo recipients were either hospitalized or died in the same time window.
In addition, there were eight deaths in the cohort of 377 placebo recipients but no deaths among the 385 molnupiravir recipients.
The MOVe-OUT study, which evaluated from patients enrolled on or before August 5, focused on participants with at least one risk factor linked with poor disease outcomes.
Molnupiravir also appeared to be effective against a range of SARS-CoV-2 variants, including Delta (B.1.617.2), Gamma (P.1) and Mu (B.1621).
In addition, molnupiravir appeared to be well tolerated in subjects with adverse reactions similar between the molnupiravir and placebo cohorts.
An independent Data Monitoring Committee and the FDA recommended halting the study early based on the positive results.
Pfizer recently announced that it launched a Phase 2/3 study for its SARS-CoV2 antiviral candidate PF-07321332.