Merck and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19
26 November 2021 - 10:45PM
Business Wire
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and Ridgeback Biotherapeutics today provided an update on
the MOVe-OUT study of molnupiravir (MK-4482, EIDD-2801), an
investigational oral antiviral medicine for COVID-19. Data are now
available from all enrolled participants (n=1433). In this study
population, molnupiravir reduced the risk of hospitalization or
death from 9.7% in the placebo group (68/699) to 6.8% (48/709) in
the molnupiravir group, for an absolute risk reduction of 3.0% (95%
confidence interval [CI]: 0.1, 5.9; nominal p-value=0.0218) and a
relative risk reduction of 30% (relative risk 0.70; 95% CI: 0.49,
0.99). Nine deaths were reported in the placebo group, and one in
the molnupiravir group. The adverse event profile for molnupiravir
remained consistent with the profile reported at the planned
interim analysis.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20211126005279/en/
Based on the study design, the definitive evaluation of efficacy
was considered complete at the planned interim analysis, when the
statistical criterion for success was met and enrollment in the
study was discontinued at the recommendation of the external Data
Monitoring Committee and agreed to by the U.S. Food and Drug
Administration (FDA). As previously reported, at the planned
interim analysis, molnupiravir significantly reduced the risk of
hospitalization or death from 14.1% (53/377) in the placebo group
to 7.3% (28/385) in the molnupiravir group (absolute risk reduction
6.8%; 95% CI: 2.4, 11.3; p=0.0012), for a relative risk reduction
of 48% (relative risk 0.52; 95% CI: 0.33, 0.80).
The interim analysis and the additional analyses support the
efficacy and overall favorable benefit-risk assessment of
molnupiravir for the treatment of mild to moderate COVID-19 in
adults at high risk for disease progression. Merck has shared these
additional analyses with the FDA and they will be presented to the
FDA’s Antimicrobial Drugs Advisory Committee on Nov. 30th.
Molnupiravir is being developed by Merck and Ridgeback for the
treatment of mild to moderate coronavirus disease 2019 (COVID-19)
in adults with a positive SARS-CoV-2 diagnostic test and who are at
high risk for progression to severe COVID-19, including
hospitalization or death. Molnupiravir has been authorized for use
in the U.K. The FDA is reviewing Merck’s application for Emergency
Use Authorization. The European Medicines Agency (EMA) is reviewing
Merck’s application for marketing authorization following a
positive scientific opinion under Article 5.3 regulation 726/2004,
which is intended to support national decision-making on the
possible use of molnupiravir prior to marketing authorization.
These regulatory applications for molnupiravir are based on the
pre-specified interim analysis based on data from 762 patients,
which is the primary analysis of the study.
Merck and Ridgeback Biotherapeutics have conducted a rigorous
development program for molnupiravir, and believe that molnupiravir
has the potential to address a significant unmet medical need for
an oral medicine for adults with COVID-19 who are at risk for
progressing to severe COVID-19 and/or hospitalization. We look
forward to working with the FDA and other agencies as they review
our applications.
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 is being studied as a single medicine, without the use
of concomitant medicines and without food intake restrictions or
dose modifications based on renal or hepatic impairment. Based on
available data, no known drug interactions with molnupiravir have
been identified.
Molnupiravir was invented at Drug Innovations at Emory (DRIVE),
LLC, a not-for-profit biotechnology company wholly owned by Emory
University; Emory/DRIVE received some research funding from the
U.S. Department of Defense and the National Institutes of Health.
Molnupiravir is being developed by Merck & Co., Inc. in
collaboration with Ridgeback Biotherapeutics. Ridgeback received an
upfront payment from Merck and also is eligible to receive
contingent payments dependent upon the achievement of certain
developmental and regulatory approval milestones. Any profits from
the collaboration will be split between the partners equally. Since
licensed by Ridgeback, all funds used for the development of
molnupiravir have been provided by Merck and Ridgeback.
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. The team at Ridgeback is dedicated to
developing life-saving and life-changing solutions for patients and
diseases that need champions as well as providing global access to
these medicines. In line with Ridgeback’s mission for equitable
global access, all Ridgeback services and treatment for Ebola
patients in Africa are delivered free of charge.
About Merck
For over 130 years, Merck, known as MSD outside the United
States and Canada, 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. We
demonstrate our commitment to patients and population health by
increasing access to health care through far-reaching policies,
programs and partnerships. Today, Merck 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.merck.com and connect with
us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA.
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline candidates that
the candidates will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the global outbreak of novel coronavirus disease
(COVID-19); the impact of pharmaceutical industry regulation and
health care legislation in the United States and internationally;
global trends toward health care cost containment; technological
advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining
regulatory approval; the company’s ability to accurately predict
future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign
risk; dependence on the effectiveness of the company’s patents and
other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2020
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211126005279/en/
Media Contacts: Melissa Moody (215) 407-3536 Patrick Ryan (973)
275-7075 Ridgeback Media Contact: Chrissy Carvalho
Chrissy@goldin.com
Investor Contacts:
Peter Dannenbaum (908) 740-1037 Raychel Kruper (908)
740-2107
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024