Merck Announces Topline Results from Phase 2b/3 Trial of Clesrovimab (MK-1654), an Investigational Respiratory Syncytial Virus Preventative Monoclonal Antibody for Infants
23 Julio 2024 - 5:45AM
Business Wire
Clesrovimab met all primary safety and
efficacy endpoints
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today announced positive topline results from its Phase
2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654),
the company’s investigational prophylactic monoclonal antibody
designed to protect infants from respiratory syncytial virus (RSV)
disease. In the trial, clesrovimab met its primary safety and
efficacy endpoints, including reducing medically attended lower
respiratory infections (MALRI) caused by RSV through Day 150.
Detailed findings of the study will be presented at an upcoming
scientific congress and Merck plans to file these data with global
regulatory authorities.
“RSV is highly contagious and can cause inflammation in the
airways of infants leading to difficulty breathing. As a widespread
illness globally, RSV is the leading cause of hospitalization for
healthy infants,” said Dr. Paula Annunziato, senior vice president,
infectious diseases and vaccines, Global Clinical Development,
Merck Research Laboratories. “We are encouraged by these findings
and look forward to working with regulators to provide a new option
to help address the impact of RSV on infants and their
families."
About MK-1654-004
MK-1654-004 (NCT04767373) is a Phase 2b/3 double-blind,
randomized, placebo-controlled study to evaluate the safety and
efficacy of clesrovimab in healthy preterm and full-term infants.
Participants were randomized to receive either a single dose of
clesrovimab or placebo. The primary endpoints include the incidence
of participants with RSV-associated medically attended lower
respiratory infection (MALRI) from Day 1 (post dose) to Day 150 as
compared to placebo and safety. Safety measures assessed included
the percentage of participants with any injection-related adverse
events (AEs), AEs of special interest (AESIs) solicited systemic
AEs, or serious adverse events (SAEs).
About Clesrovimab (MK-1654)
Clesrovimab (MK-1654) is an investigational extended half-life
monoclonal antibody (mAb) developed as a passive immunization for
the prevention of RSV-associated medically attended lower
respiratory infection (MALRI). Clesrovimab is being studied in
infants (pre-term and full-term) to provide rapid, durable
protection through their first RSV season with a single, fixed-dose
administration.
About RSV
Respiratory syncytial virus (RSV) is a contagious virus that
causes widespread seasonal infection with a worldwide burden in
infants and older adults. There is high unmet need for preventative
options in both healthy and high-risk infants. Globally, it is the
leading cause of hospitalization for healthy infants under a year
old. RSV can lead to serious respiratory conditions like
bronchiolitis and pneumonia, causing an estimated 101,000 deaths a
year worldwide in children under five.
About Merck
At Merck, known as MSD outside of the United States and Canada,
we are unified around our purpose: We use the power of leading-edge
science to save and improve lives around the world. For more than
130 years, we have brought hope to humanity through the development
of important medicines and vaccines. We aspire to be the premier
research-intensive biopharmaceutical company in the world – and
today, we are at the forefront of research to deliver innovative
health solutions that advance the prevention and treatment of
diseases in people and animals. We foster a diverse and inclusive
global workforce and operate responsibly every day to enable a
safe, sustainable and healthy future for all people and
communities. For more information, visit www.merck.com and connect
with us on X (formerly Twitter), Facebook, Instagram, YouTube and
LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA
This news release of Merck & Co., Inc., Rahway, 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 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 Annual
Report on Form 10-K for the year ended December 31, 2023 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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