- At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died
- MSD and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
- European Medicines Agency (EMA) has Initiated a Rolling Review for Molnupiravir
- If Authorized, Molnupiravir Could be the First Oral Antiviral Medicine for COVID-19
BEIRUT, November 3, 2021 – MSD, (known as Merck & Co., Inc., in the United States and Canada) and Ridgeback Biotherapeutics recently announced that Molnupiravir, 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. At the interim analysis, Molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received Molnupiravir were either hospitalized or died through Day 29 following randomization compared with 14.1% of placebo-treated patients. 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 has been stopped early due to these positive results.
Based on the positive results, MSD has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for Molnupiravir, the companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months. Furthermore, the European Medicines Agency (EMA) has initiated a rolling review for the medicine. If granted Emergency Use Authorization and marketing authorization by the European commission, Molnupiravir could be the first oral antiviral medicine for the treatment of COVID-19. MSD and Ridgeback are actively working to submit applications to other regulatory agencies worldwide.
Sandra Khoury, Managing Director, MSD Levant said: “With hospitalizations and deaths due to COVID-19 still increasing, this is an important option that will save lives and make a significant difference in the fight against this pandemic. As MSD, we recognize the need for more treatments, and we look forward to the opportunity to bring Molnupiravir to patients around the world once it is approved by regulatory authorities.” Ms. Khoury added: “We continue to strive to discover, develop and provide innovative products and services to the patients in the region so that they receive the most advanced treatments.”
In addition to treatment, a study is also underway to investigate Molnupiravir for the prevention of COVID-19. MOVe-AHEAD is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of Molnupiravir in preventing the spread of COVID-19 within households.
“With the virus still circulating widely, and therapeutic options that are currently available being infused and requiring 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 we are grateful to the clinical investigators and patients who have helped bring us to this important milestone. We are pleased to partner with MSD and regulatory authorities to help provide Molnupiravir to the people who need it around the world.”
More About the MOVe-OUT Study
The MOVe-OUT trial (MK-4482-002) (NCT04575597) was a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19. Patients enrolled in the study were unvaccinated against SARS-CoV-2, had at least one risk factor associated with poor disease outcomes, and symptom onset within five days prior to randomization. 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.
The Phase 3 portion of the MOVe-OUT trial was conducted globally, including in more than 170 planned sites in countries including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United States. For further information about the MOVe-OUT trial, please visit clinicaltrials.gov.
The most common risk factors for poor disease outcome included obesity, older age (>60 years), diabetes mellitus and heart disease. Delta, Gamma and Mu variants accounted for nearly 80% of the baseline viral variants that had been sequenced at the time of the interim analysis. Recruitment in Latin America, Europe, and Africa accounted for 56%, 23% and 15% of the study population, respectively.
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. 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%).
About Molnupiravir
Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown Molnupiravir to be active against the most common SARS-CoV-2 variants.
Molnupiravir 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 MSD in collaboration with Ridgeback Biotherapeutics.
Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of Molnupiravir in preventing the spread of COVID-19 within households. For more information, please visit http://merckcovidresearch.com.
About MSD Efforts to Enable Access to Molnupiravir, if it is Granted EUA or Approval
In anticipation of the results from MOVe-OUT, MSD has been producing Molnupiravir at risk. MSD expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.
MSD has entered into supply and purchase agreements for Molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.
MSD is committed to providing timely access to Molnupiravir globally, if it is authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.
As part of its commitment to widespread global access, MSD previously announced that the company has entered into non-exclusive voluntary licensing agreements for Molnupiravir with established generic manufacturers to accelerate availability of Molnupiravir in more than 100 low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.
About MSD
For over 130 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals — including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases — as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.
About Ridgeback Biotherapeutics
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes Molnupiravir for the treatment of COVID-19. Development of Molnupiravir is entirely funded by Ridgeback Biotherapeutics and MSD. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.