Global healthcare giant Merck & Co. Inc. (MRK:NYSE), known as MSD outside of the U.S. and Canada, which manufactures and markets biologic therapies, prescription medicines, vaccines and animal health products worldwide and Ridgeback Biotherapeutics L.P., today announced that "molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19."
The companies stated that data from a planned interim analysis in the Phase 3 MOVe-OUT study demonstrated that molnupiravir significantly reduced the risk of hospitalization or death by around 50%. The firms advised that 7.3% of the 385 patients who were administered molnupiravir were either hospitalized or had died through Day 29 of observation compared to 14.1% of the 377 individuals in the placebo group.
The companies noted that through 29 days of commencing treatment, there were zero deaths reported in patients who received molnupiravir, though 8 deaths were recorded in patients who received placebo.
Importantly, an independent Data Monitoring Committee recommended in consultation with the U.S. Food and Drug Administration (FDA), that the enrollment in the clinical trial should cease due to the highly positive results observed in the randomized cohort who were given molnupiravir.
Based upon the strong positive findings Merck & Co. intends to quickly expedite the submission of an application for Emergency Use Authorization (EUA) to the FDA and is also formulating plans to submit marketing applications to other worldwide regulatory bodies. The companies highlighted that "if authorized, molnupiravir could be the first oral antiviral medicine for COVID-19."
Merck's CEO and President Robert M. Davis commented, "More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world. 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…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."
Ridgeback Biotherapeutics' CEO Wendy Holman remarked, "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."
"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," CEO Holman added.
The preplanned interim analysis evaluated data from 775 patients in the Phase 3 MOVe-OUT trial. The trial initially planned for enrollment of 1,550 patients and was about 90% enrolled when the decision was made to stop recruiting participants in the study based upon the positive interim findings.
The Phase 3 MOVe-OUT trial was conducted at over 170 sites in more than 20 countries in the Americas, Europe, Asia and Africa. To be included in the study, patients must have been diagnosed with laboratory-confirmed mild-to-moderate COVID-19 and have presented symptom(s) onset within five days of study randomization. Additionally, only those individuals who had at least one risk factor associated with poor disease outcome were at admitted to join the study. These higher risk factors included diabetes mellitus, heart disease, obesity and older age (>60 years).
The companies reported that that interim data showed that "molnupiravir reduced the risk of hospitalization and/or death across all key subgroups and efficacy was not affected by either timing of symptom onset or underlying risk factor." The report mentioned that molnupiravir was showed consistent efficacy across the Gamma, Delta and Mu variants in 40% of participants where viral sequencing data was available.
In the expectation and hope that the FDA grants EUA approval for molnupiravir, Merck indicated that it has already commenced production of molnupiravir at its own risk and plans to manufacture 10 million courses of treatment by year-end 2021 along with many more additional doses in 2022.
The report advised that Merck entered into a procurement agreement earlier this year to supply approximately 1.7 million courses of molnupiravir to the U.S. Government, upon EUA or FDA approval. The company also has also entered into supply and purchase agreements for molnupiravir with some other governments outside of the U.S.
Molnupiravir (MK-4482/EIDD-2801) was described in the report as "an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. The drug was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University and is being developed by Merck & Co. Inc. in collaboration with Ridgeback Biotherapeutics." Molnupiravir has also been studied in other animal models to investigate potential use in treatment of Ebola, Equine Encephalitis, Influenza and Respiratory Syncytial Virus.
Ridgeback Biotherapeutics is a private biotechnology company based in Miami, Fla. The firm focuses on developing treatments for emerging infectious diseases. Ridgeback listed that "it markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19."
Merck is headquartered in Kenilworth, N.J., and is one of the world's largest global healthcare companies with a market cap of around $190 billion. The firm is known as MSD outside of the U.S. and Canada. The company provides healthcare services and develops, manufactures and markets animal health products, biologic therapies, prescription medicines and vaccines worldwide. The company stated that it endeavors to be "the premier research-intensive biopharmaceutical company in the world."
Merck started Friday with a market cap around $190.1 billion with approximately 2.531 billion shares outstanding and a short interest of about 1.1%. MRK shares opened over 8% higher at $81.56 (+$6.45, +8.59%) over Thursday's $75.11 closing price and reached a new 52-week high price Friday morning of $84.34. The stock traded Friday between $80.63 and $84.34 per share and closed at $81.40 (+$6.29, +8.37%).
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