Merck (MSD) and Ridgeback Biotherapeutics have developed a pill that it says “significantly reduced the risk of hospitalization or death” following an infection of covid-19.
Called molnupiravir, the pill is in phase three trials with at risk, non-hospitalized adult patients with mild-to-moderate covid-19.
In a press statement, Merck says its interim analysis of molnupiravir shows it reduced the risk of hospitalization or death by approximately 50%. The firm says 7.3% of patients who received molnupiravir were either hospitalized or died by day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients.
News of the new treatment saw shares in vaccine makers Pfizer et al drop in value on the New York stockmarket on Friday 1 October 2021.
Shares of Pfizer (NYSE:PFE) were down by 1.6% after having declined by as much as 3.1% earlier in the Friday session. Pfizer’s covid vaccine partner, BioNTech (NASDAQ:BNTX), fared even worse, with its stock sliding by 11.9%.
Merck says that patients treated with the new pill, and who survived to day 29, survived. While eight patients not treated – given a placebo – had died.
Merck says: “At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results.
“Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.”
The company says more tools and treatments are urgently needed to fight the covid-19 pandemic.
“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,” says the firm.
“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.
“We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic. Our partnership with Merck is critical to ensuring rapid global access if this medicine is approved, and we appreciate the collaborative effort to reach this important stage of development.”About the Results of the Planned Interim Analysis
The planned interim analysis evaluated data from 775 patients who were initially enrolled in the Phase 3 MOVe-OUT trial on or prior to Aug. 5, 2021. At the time of the decision to stop recruitment based on the compelling interim efficacy results, the trial was approaching full recruitment of the Phase 3 sample size of 1,550 patients, with more than 90% of the intended sample size already enrolled.
Eligibility criteria required that all patients had laboratory-confirmed mild-to-moderate covid-19, with symptom onset within 5 days of study randomization.
All patients were required to have at least one risk factor associated with poor disease outcome at study entry. Molnupiravir reduced the risk of hospitalization and/or death across all key subgroups; efficacy was not affected by timing of symptom onset or underlying risk factor. 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.
The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). Similarly, the incidence of drug-related adverse events was also comparable (12% and 11%, respectively). Fewer subjects discontinued study therapy due to an adverse event in the molnupiravir group (1.3%) compared to the placebo group (3.4%).
Read the full Merck press statement here.