Molnupiravir, co-developed with Ridgeback Biotherapeutics, is administered orally and works by inhibiting the replication of the coronavirus inside the body. The companies plan to seek emergency authorization for the drug in the US as soon as possible, the company said in a statement.
An interim analysis of a Phase-3 study, based on 775 trial participants, found that 7.3 percent of patients treated with molnupiravir were hospitalized within 29 days. Of the patients who received a placebo, 14.1 percent were hospitalized or died by day 29. No deaths were reported in patients who were given molnupiravir within the 29-day period, while eight deaths were reported in placebo-treated patients.
The drug's efficacy was not affected by the timing of symptom onset or underlying risk factors. In addition, based on the participants with available viral sequencing data (approximately 40 percent of participants), molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu.
"With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic," Merck CEO and President Robert M. Davis, said in the statement.
"We will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible," he added.
Moreover, adverse events were comparable in the molnupiravir and placebo groups, with around 10 percent reporting adverse events. The Phase 3 trial was conducted at more than 170 sites, in countries including the US, Brazil, Italy, Japan, South Africa, Taiwan, and Guatemala.