Washington: Merck on Friday announced its anti-viral drug has shown "compelling results" in clinical trials - halving the risk of hospitalisation or death for patients with mild or moderate cases of Covid.
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 authorisation 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 per cent of patients treated with molnupiravir were hospitalised within 29 days. Of the patients who received a placebo, 14.1 per cent were hospitalised 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 timing of symptom onset or underlying risk factor. In addition, based on the participants with available viral sequencing data (approximately 40 per cent 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 per cent 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.
Molnupiravir has also been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission.
If authorised by regulatory bodies, molnupiravir could be the first oral antiviral medicine for Covid. Antiviral treatments now in use, such as remdesivir, are administered intravenously, CNBC reported.
Merck has already begun producing molnupiravir. The pharmaceutical giant expects to produce 10 million courses of treatment by the end of 2021, and more doses in 2022.
The company agreed earlier this year to supply the US with around 1.7 million courses of molnupiravir if it receives emergency use authorisation or full approval from the FDA.