The findings reported on a secondary
objective to reduce time to negativity of infectious SARS-CoV-2
virus isolation from nasopharyngeal swabs from participants with
symptomatic COVID-19
Primary and other secondary findings to be
presented at an upcoming medical meeting
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and Ridgeback Biotherapeutics, LP today announced
preliminary results from Ridgeback’s Phase 2a randomized,
double-blind, placebo-controlled trial to evaluate the safety,
tolerability, and efficacy to eliminate SARS-CoV-2 viral RNA of
molnupiravir (EIDD-2801/MK-4482), an investigational oral antiviral
agent. The companies today reported findings on one secondary
objective from the Phase 2a study, showing a reduction in time
(days) to negativity of infectious virus isolation in
nasopharyngeal swabs from participants with symptomatic SARS-CoV-2
infection, as determined by isolation in Vero cell line culture.
These preliminary findings were presented today during Science
SpotlightsTM at the 2021 Conference on Retroviruses and
Opportunistic Infections (CROI 2021). Findings from the primary
efficacy and safety endpoints and additional secondary objectives
will be presented at an upcoming medical meeting.
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This multi-center U.S. Phase 2a study enrolled 202
non-hospitalized adults who had signs or symptoms of COVID-19
within 7 days and confirmed active SARS-CoV-2 infection. The
primary efficacy objective was reduction in time to viral
negativity measured by reverse transcriptase polymerase chain
reaction (RT-PCR) analysis of nasopharyngeal swabs. Periodic
samples were collected for virologic analysis. Of the 182
participants with an evaluable nasopharyngeal swab, 42% (78/182)
showed detectable levels of cultured virus at baseline. The full
study results remain blinded and will be shared at a later date, as
they become available. Other Phase 2 and Phase 2/3 studies are
underway.
Today’s presentation described findings from the secondary
endpoint of reduction in time (days) to negativity of infectious
virus isolation in nasopharyngeal swabs from participants with
symptomatic SARS-CoV-2 infection, as determined by isolation in
Vero cell line culture. At day 5, there was a reduction (nominal
p=0.001, not controlled for multiplicity) in positive viral culture
in subjects who received molnupiravir (all doses) compared to
placebo: 0% (0/47) for molnupiravir and 24% (6/25) for placebo.
Of 202 treated participants, no safety signals have been
identified and of the 4 serious adverse events reported, none were
considered to be study drug related. In addition to the ongoing
clinical studies, Merck has conducted a comprehensive nonclinical
program to characterize the safety profile of molnupiravir. This
program included assays such as Big Blue and PIG-a designed to
provide a robust measure of a drug or chemical’s ability to induce
mutations in vivo. Animals were administered molnupiravir for
longer and at higher doses (mg/Kg) than those employed in human
studies. The totality of the data from these studies indicates that
molnupiravir is not mutagenic or genotoxic in in vivo mammalian
systems.
“We are very pleased to share our initial Phase 2 infectivity
data at this important conference, which remains at the forefront
for critical clinical scientific information in infectious
diseases,” shared Dr. Wendy Painter, Chief Medical Officer of
Ridgeback Biotherapeutics. “At a time where there is unmet need for
antiviral treatments against SARS-CoV-2, we are encouraged by these
preliminary data.”
“The secondary objective findings in this study, of a quicker
decrease in infectious virus among individuals with early COVID-19
treated with molnupiravir, are promising and if supported by
additional studies, could have important public health
implications, particularly as the SARS-CoV-2 virus continues to
spread and evolve globally,” noted Dr. William Fischer, lead
investigator of the EIDD-2801 2003 study and Associate Professor of
Medicine, Division of Pulmonary Diseases and Critical Care Medicine
at the University of North Carolina School of Medicine.
“We continue to make progress in our Phase 2/3 clinical programs
evaluating molnupiravir in both outpatient and hospital settings
and plan to provide updates when appropriate,” said Dr. Roy Baynes,
senior vice president and head of global clinical development,
chief medical officer, Merck Research Laboratories.
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. Since licensed by Ridgeback all funds
used for the development of EIDD-2801 by Ridgeback 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 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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Merck Media: Ian McConnell (973) 901-5722 Patrick Ryan (973)
275-7075 Investors: Peter Dannenbaum (908) 740-1037 Raychel Kruper
(908) 740-2107 Ridgeback Media Chrissy Carvalho (646) 660-8641
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