Interim Results from Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate CO...
July 12 2021 - 06:45AM
Business Wire
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and Ridgeback Biotherapeutics announced today the
presentation of previously announced Phase 2 interim results from
two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of
molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral
therapeutic. The data were presented during the late-breaking
clinical trials session at the European Congress of Clinical
Microbiology & Infectious Diseases (ECCMID). The Phase 3
portion of the global MOVe-OUT trial studying molnupiravir in
non-hospitalized adult patients with laboratory-confirmed COVID-19
and at least one risk factor associated with poor disease outcomes
is underway. In addition, Merck plans to initiate a clinical
program to evaluate molnupiravir for post-exposure prophylaxis in
the second half of 2021.
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“It continues to be critically important to advance potential
antiviral treatments to address the devastating impact of COVID-19
globally,” said Dr. Roy Baynes, senior vice president and head of
global clinical development, chief medical officer, Merck Research
Laboratories. “If successful, molnupiravir could help address the
continued urgent need for therapeutics.”
“These data are promising, and we are pleased to be able to
present the Phase 2 interim results for molnupiravir while we
proceed with the Phase 3 portion of MOVe-OUT in non-hospitalized
patients,” said Wendy Holman, chief executive officer, Ridgeback
Biotherapeutics. “There remains a great need for a range of
solutions for the pandemic, and we are hopeful that molnupiravir
will play a role in helping patients.”
For further information regarding our clinical trials, please
visit https://merckcovidresearch.com/ or
https://clinicaltrials.gov.
About Molnupiravir
Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally
bioavailable form of a potent ribonucleoside analog that inhibits
the replication of multiple RNA viruses including SARS-CoV-2, the
causative agent of COVID-19. Molnupiravir has been shown to be
active in several models of SARS-CoV-2, including for prophylaxis,
treatment, and prevention of transmission, as well as SARS-CoV-1
and MERS. EIDD-2801 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. Since licensed by
Ridgeback, all funds used for the development of EIDD-2801/MK-4482
have been provided by Wayne and Wendy Holman and Merck.
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 Merck & Co., Inc. 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 Biotherapeutics is dedicated to working toward finding
life-saving and life-changing solutions for patients and diseases
that need champions.
About Merck
For 130 years, Merck, known as MSD outside of 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 products that
the products 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).
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version on businesswire.com: https://www.businesswire.com/news/home/20210712005251/en/
Media: Ian R. McConnell (973) 901-5722
Melissa Moody (215) 407-3536
Ridgeback Media: Chrissy Carvalho (646) 660-8641
Investor: Peter Dannenbaum (908) 740-1037
Courtney Ronaldo (908) 740-6132
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