What can we help you find?

May 8, 2019 8:00 am ET

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

KENILWORTH, N.J.–(BUSINESS WIRE)–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 37^th 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).

Media:
Pamela Eisele
(267) 305-3558

Kristen Drake
(908) 740-6179

Investors:
Teri Loxam
(908) 740-1986

Michael DeCarbo
(908) 740-1807