In PNEU-AGE (V114-019), V114 Demonstrated
Non-inferiority to the Currently Available 13-valent Pneumococcal
Conjugate Vaccine for Shared Serotypes and Met Study-Defined
Superiority Criteria for Unique Serotypes 22F and 33F and Shared
Serotype 3
Application for V114 Licensure in Adults to
Be Submitted by Year-End
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced that two Phase 3 studies evaluating the
safety, tolerability and immunogenicity of V114, the company’s
investigational 15-valent pneumococcal conjugate vaccine, met their
primary immunogenicity objectives. The pivotal PNEU-AGE (V114-019)
study in healthy adults 50 years of age or older demonstrated that
V114 is non-inferior to the currently available 13-valent
pneumococcal conjugate vaccine (PCV13) for the 13 serotypes
targeted by both vaccines and superior for serotypes 22F and 33F,
the two serotypes targeted by V114 but not PCV13. These results are
based on opsonophagocytic activity (OPA) responses – a measure of
vaccine-induced functional antibodies. The PNEU-AGE study also met
the key secondary immunogenicity objective, demonstrating
superiority of V114 compared to PCV13 for serotype 3, a leading
cause of invasive pneumococcal disease globally. In another Phase 3
study, PNEU-TRUE (V114-020), in healthy adults 50 years of age or
older, V114 met its primary immunogenicity objective demonstrating
equivalent immune response across all 15 serotypes for three
different lots of V114. In both studies, V114 was generally well
tolerated, with a safety profile comparable to PCV13 and consistent
with that observed for V114 in previously reported studies. These
findings, and additional Phase 3 data from Merck’s clinical
program, will be presented at a scientific congress in the future
and will form the basis of global regulatory licensure
applications, beginning with the U.S. Food and Drug Administration,
before the end of the year.
“Diseases caused by serotypes not covered by the currently
available pneumococcal conjugate vaccine are increasing worldwide
and can vary by country or region. Additionally, we continue to see
pneumococcal disease caused by serotypes included in the existing
pneumococcal vaccines,” said Dr. Roy Baynes, senior vice president
and head of global clinical development, chief medical officer,
Merck Research Laboratories. “Continued scientific innovation in
pneumococcal disease prevention is needed to target the serotypes
that pose the greatest risk to specific populations while
maintaining immune response as new serotypes are added. These Phase
3 data demonstrated that V114 generated a robust immune response to
all 15 serotypes included in the vaccine and reinforce the
potential for this investigational vaccine to help protect adults
against pneumococcal disease.”
There are more than 90 different types of pneumococcal bacteria,
which can affect adults differently than children. Pneumococcal
serotypes not in the currently licensed conjugate vaccine, such as
22F and 33F, are commonly associated with invasive pneumococcal
disease worldwide. Serotypes 22F and 33F currently cause 13 percent
of the invasive pneumococcal disease seen among adults aged 65 and
older in the U.S., and seven to 12 percent of the adult cases seen
across Europe. Additionally, serotype 3 remains one of the top
causes of invasive pneumococcal disease in adults and children
despite being included in the currently available pneumococcal
vaccines. In the U.S., 15 percent of invasive pneumococcal disease
among adults aged 65 and older continues to be caused by serotype
3; this ranges from 12 to 18 percent of cases in adults across
European countries.
The V114 Phase 3 clinical development program is comprised of 16
trials investigating the safety, tolerability and immunogenicity of
V114 in a variety of populations who are at increased risk for
pneumococcal disease including healthy older adults and children,
as well as people who are immunocompromised or have certain chronic
medical conditions. An overview of the late-stage development
program is available here.
About PNEU-AGE
PNEU-AGE is a Phase 3, multi-center, randomized, double-blind,
active comparator-controlled study evaluating the safety,
tolerability, and immunogenicity of V114 in healthy adults 50 years
of age or older (n=1,205). The study met its immunogenicity and
safety objectives. Immune responses were measured at baseline and
30 days post-vaccination, and immunogenicity comparisons were
assessed based on study-defined criteria. Results of the primary
immunogenicity analyses demonstrated:
- Non-inferiority of V114 to the currently available 13-valent
pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes
and superiority to PCV13 for serotypes 22F and 33F, the two
serotypes unique to V114, as assessed by the serotype-specific
opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs).
- Superiority of V114 compared to PCV13 for the two unique
serotypes in V114 as assessed by the proportion of participants
with a ≥4-fold rise in serotype-specific OPA responses (from
pre-vaccination to 30 days post-vaccination).
Results of the key secondary immunogenicity analyses
demonstrated:
- Superiority of V114 compared to PCV13 for serotype 3 as
assessed by the OPA GMTs and the proportions of participants with a
≥4-fold rise in OPA responses.
Results of the safety analyses demonstrated that V114 was
generally well tolerated with a safety profile comparable to PCV13
and consistent with that observed in previously reported
studies.
About PNEU-TRUE
PNEU-TRUE is a Phase 3, multi-center, randomized, double-blind,
active comparator-controlled, lot-to-lot consistency study
evaluating the safety, tolerability, and immunogenicity of V114 in
healthy adults 50 years of age or older (n=2,340). In the study,
V114 met all primary immunogenicity objectives, demonstrating
equivalent immune response as assessed by serotype specific OPA
GMTs for all 15 serotypes in V114 across three different
manufactured lots of V114 at 30 days post-vaccination. Results of
the safety analyses demonstrated that all three lots of V114 were
generally well tolerated with a safety profile comparable to PCV13
and consistent with that observed in previously reported
studies.
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 invasive pneumococcal disease worldwide and are not
contained in the pneumococcal conjugate vaccine currently licensed
for use in adults.
About Pneumococcal Disease
The global prevalence of pneumococcal disease, an infection
caused by bacteria called Streptococcus pneumoniae, is evolving.
Highly aggressive strains, or serotypes, threaten to put more
people at risk for non-invasive pneumococcal illnesses such as
pneumococcal pneumonia (when it is confined to the lungs),
sinusitis, and otitis media (middle ear infection), and invasive
pneumococcal illnesses such as pneumococcal bacteremia (infection
in the bloodstream), bacteremic pneumonia (pneumonia with
bacteremia) and pneumococcal meningitis (infection of the coverings
of the brain and spinal cord). While healthy adults and children
can suffer from pneumococcal disease, patient populations
particularly vulnerable to infection include children under the age
of 2, older adults such as those 65 years of age and older, and
people with immunosuppressive or certain 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 125 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 2019
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/20200909005303/en/
Media: Pamela Eisele (267) 305-3558 Kim Hamilton (908) 391-0131
Investor: Peter Dannenbaum (908) 740-1037 Raychel Kruper (908)
740-2107
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