V114 Met Primary Endpoint by Demonstrating
Noninferiority to PCV13 for all Shared Serotypes, and an Immune
Response for Two Additional Serotypes
Data Support Continued Progression of Phase
3 Studies with V114
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today announced results from a Phase 2 trial
(NCT02982972) evaluating the safety,
tolerability and immunogenicity of V114, the company’s
investigational 15-valent pneumococcal conjugate vaccine, as
compared to the currently available 13-valent pneumococcal
conjugate vaccine (PCV13) in healthy infants 6-12 weeks of age. In
the study, designated V114-008, V114 met its primary endpoint by
demonstrating noninferiority for the 13 serotypes contained in both
vaccines. V114 also induced an immune response in infants for two
additional disease-causing serotypes, 22F and 33F, which are not
contained in PCV13. In January 2019, V114 received a Breakthrough
Therapy Designation from the U.S. Food and Drug Administration
(FDA) for the prevention of invasive pneumococcal disease (IPD)
caused by the vaccine serotypes in pediatric patients 6 weeks to 18
years of age. The FDA’s decision was informed in part by
immunogenicity data from this Phase 2 study, V114-008, and the
Phase 1/2 V114-005 study in healthy adults and infants. Results of
the V114-008 study were presented during an oral session at the
37th Annual Meeting of the European Society for Paediatric
Infectious Diseases (ESPID) in Ljubljana, Slovenia, and reinforce
continued progression of Phase 3 clinical studies with V114.
“Children under the age of two are at increased risk for
pneumococcal infection, which in some cases may lead to serious
illnesses like pneumococcal pneumonia,” said Dr. David Greenberg,
study investigator and physician in the Pediatric Infectious
Disease Unit of Soroka University Medical Center in Beer-Sheva,
Israel. “These Phase 2 data evaluating V114 in infants are
encouraging and mark important progress to helping expand
protection against pneumococcal disease for this vulnerable patient
population.”
V114-008, a double-blind, randomized, Phase 2 trial, compared
the safety, tolerability, and immunogenicity of two different
clinical lots of V114 (n=350 for lot 1; n=347 for lot 2) to PCV13
(n=347) in approximately 1,050 healthy infants at two, four, six
and 12-15 months of age. In the study, the percentage of subjects
who achieved the WHO-accepted threshold of immune response
(IgG≥0.35 mcg/mL) with either lot of V114 was noninferior to the
percentage seen with PCV13 for the 13 serotypes shared between the
two vaccines. For serotype 3, the percentage of subjects who
achieved this threshold of immune response was higher for V114
(96.0% for lot 1; 94.1% for lot 2) compared with PCV13 (71.8%). For
the two serotypes not included in PCV13, serotype 22F and serotype
33F, the percentage of subjects who achieved the defined threshold
of immune response with V114 was above 98% (98.9% for lot 1; 98.5%
for lot 2) and above 87% (87.7% for lot 1; 90.1% for lot 2),
respectively. Results were consistent between the two lots of V114
studied.
Safety profiles were evaluated after each dose and throughout
the study. In the study, the adverse event profile for V114,
including the number of serious adverse events (AEs), was found to
be comparable to PCV13. The percentage of subjects who reported
clinical AEs and serious AEs was similar in all treatment arms. The
most commonly reported adverse events were injection site
reactions, the majority of which were mild to moderate in severity
and of short duration.
“These new data for our investigational pneumococcal disease
vaccine V114 build on Merck’s century-long heritage in vaccines and
our commitment to improving global health through protection from
infectious diseases,” said Dr. Nicholas Kartsonis, senior vice
president and head of vaccine and infectious diseases clinical
research at Merck Research Laboratories. “We are deeply committed
to advancing compounds such as V114 that have the potential to make
a meaningful impact on the burden of pneumococcal disease.”
Merck has a broad clinical development program for V114
currently comprised of 11 Phase 3 clinical trials. These studies
are investigating V114 in adults (NCT03480763, NCT03615482), in the
pediatric population (NCT03692871, NCT03620162, NCT03885934,
NCT03893448), and in immunocompromised persons and those at
increased risk for invasive pneumococcal disease (NCT03547167,
NCT03921424, NCT03731182, NCT03480802, NCT03565900).
Additional Detail About V114-008 Study Design
In the V114-008 study, immunogenicity results were described as
the percentage of subjects who reached an internationally accepted
threshold of immune response considered to be protective (IgG≥0.35
mcg/mL). The primary immunogenicity endpoint was to demonstrate
that V114 was noninferior to PCV13 based on the proportion of
infants achieving serotype-specific IgG≥0.35 mcg/mL for all 13
serotypes in common with PCV13 at one-month following the
completion of the three dose primary series. Additionally,
serotype-specific IgG geometric mean concentrations (GMCs) were
measured at one month following the completion of the primary
series, immediately prior to the toddler dose and one month after
the toddler dose.
About V114
V114 is Merck’s investigational 15-valent pneumococcal conjugate
vaccine in Phase 3 development for the prevention of pneumococcal
disease in adults and children. V114 consists of pneumococcal
polysaccharides from 15 serotypes conjugated to a CRM197 carrier
protein, and includes serotypes 22F and 33F, which are commonly
associated with IPD worldwide.
About Pneumococcal Disease
Pneumococcal disease is an infection caused by bacteria called
Streptococcus pneumoniae. Pneumococcal disease includes
non-invasive illnesses such as pneumonia (when it is confined to
the lungs), sinusitis, and otitis media (middle ear infection); and
invasive illnesses such as bacteremia (infection in the
bloodstream), bacteremic pneumonia (pneumonia with bacteremia), and
meningitis. While healthy adults and children are at risk for
pneumococcal disease, patient populations particularly vulnerable
to infection include children under the age of 2, adults aged 65
and older, and people with immunosuppressive or chronic health
conditions.
Merck’s Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery
and development of novel medicines and vaccines to combat
infectious diseases. In addition to a combined portfolio of
vaccines and antibacterial, antiviral and antifungal medicines,
Merck has multiple programs that span discovery through late-stage
development. To learn more about Merck’s infectious diseases
pipeline, visit www.merck.com.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company 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.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. 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 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 2018
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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