Study Now Enrolling Participants Who Live in
the Same Household as Someone With Symptomatic,
Laboratory-Confirmed COVID-19
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and Ridgeback Biotherapeutics announced today the
initiation of the Phase 3 MOVe-AHEAD clinical trial to evaluate
molnupiravir, an investigational oral antiviral therapeutic, for
the prevention of COVID-19 infection. The global study is enrolling
individuals who are at least 18 years of age and reside in the same
household as someone with laboratory-confirmed SARS-CoV-2 infection
with symptoms. For more information on the molnupiravir MOVe-AHEAD
clinical trial, visit http://merckcovidresearch.com/move-ahead/ or
www.clinicaltrials.gov.
“As the pandemic continues to evolve and surges are being
reported in many places around the world, it is important that we
investigate new ways to protect individuals exposed to the virus
from becoming infected with symptomatic disease,” said Dr. Nick
Kartsonis, senior vice president, vaccines and infectious diseases,
clinical research, Merck Research Laboratories. “If successful,
molnupiravir could provide an important additional option towards
reducing the burden of COVID-19 on our communities.”
The safety and efficacy of molnupiravir is also currently being
evaluated in Part 2 of the ongoing MOVe-OUT trial, which is 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 and at least one
risk factor associated with poor disease outcomes. Data from the
study is expected in the second half of 2021.
MOVe-AHEAD Study
MOVe-AHEAD (MK-4482-013) (NCT04939428) is a Phase 3 multicenter,
randomized, double-blind, placebo-controlled study to evaluate the
efficacy and safety of orally administered molnupiravir compared to
placebo in preventing the spread of SARS-CoV-2, the virus that
causes COVID-19, within households. The trial will enroll
approximately 1,332 participants who will be randomized to receive
either molnupiravir (800 mg) or placebo orally every 12 hours for
five days. The study will enroll participants who are at least 18
years of age and currently residing in the same household with
someone who received a positive test for SARS-CoV-2, has at least
one sign or symptom of COVID-19 and has not had those signs and
symptoms for more than five days. Participants are not eligible for
the trial if they have received the first dose of a COVID-19
vaccine more than seven days prior to enrollment, have previously
had COVID-19 or are showing any signs or symptoms of COVID-19.
The primary endpoints of the trial include percentage of
participants with COVID-19 (laboratory-confirmed SARS-CoV-2
infection with symptoms) through Day 14, percentage of participants
with an adverse event and percentage of participants who
discontinued study intervention due to an adverse event.
The trial is being conducted globally in countries including
Argentina, Brazil, Colombia, France, Guatemala, Hungary, Japan,
Mexico, Peru, Philippines, Romania, Russia, South Africa, Spain,
Turkey, Ukraine, and the United States.
About Molnupiravir
Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally
administered 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 preclinical models of SARS-CoV-2, including for
prophylaxis, treatment, and prevention of transmission, as well as
SARS-CoV-1 and MERS. 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 Merck
& Co., Inc. in collaboration with Ridgeback Biotherapeutics.
Since licensed by Ridgeback, all funds used for the development of
molnupiravir 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 is dedicated to working toward finding life-saving and
life-changing solutions for patients and diseases that need
champions.
About Merck
For over 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/20210901005160/en/
Media Contacts: Melissa Moody (215) 407-3536 Courtney Ronaldo
(908) 740-6132 Ridgeback Media Contact: Chrissy Carvalho (646)
660-8641 Investor Contacts: Peter Dannenbaum (908) 740-1037 Raychel
Kruper (908) 740-2107
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