Merck’s Antiviral Oral Pill Cuts Hospitalization and Death Rate by 50%, According to Study

Merck and Co. has announced on Friday that their experimental antiviral pill against COVID-19 has significantly reduced the hospitalization and death risk for those who have mild to severe symptoms.

The announcement was based on the recent results of their study on the Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19. 

At a planned interim analysis of Phase 3 MOVe-OUT trial, 775 non-hospitalized adult patients with mild-to-moderate COVID-19 who were at risk for severe symptoms participated.  All patients were required to have at least one risk factor such as obesity, older age (>60 years), diabetes mellitus, and heart disease.

In a study conducted globally, 7.3% of patients who receive the oral antiviral pill were either hospitalized or died through Day 29 following randomization, compared to 14.1% of placebo-treated patients, showing that molnupiravir reduced the risk of hospitalization or death by approximately 50%.

The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of molnupiravir compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from the time of randomization through Day 29.

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.

Based on the compelling results, the decision to stop further recruitment as per the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA).

“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics.

Merck is now planning to seek Emergency Use Authorization (EUA) in the U.S. as well as apply to regulatory agencies worldwide to provide timely access to the pill globally. If approved, molnupiravir will be the first oral medication to fight COVID-19 infection.

“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. Consistent with Merck’s unwavering commitment to save and improve lives, 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,” said Robert M. Davis, chief executive officer and president, Merck.

 

SOURCES: Merck, ClinicalTrials.gov