V116 designed to target serotypes that
account for 85% of all invasive pneumococcal disease in individuals
aged 65 and over in the United States as of 2019 1 Broad Phase 3
clinical program for V116 in vaccine-naïve and vaccine-experienced
adults planned to start in July 2022
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced the presentation of positive results from
the Phase 1/2 study, V116-001, evaluating the safety, tolerability
and immunogenicity of V116, the company’s investigational 21-valent
pneumococcal conjugate vaccine (PCV), in pneumococcal vaccine-naïve
adults 18-49 years of age (Phase 1) and 50 years of age and older
(Phase 2). In both populations, V116 met the primary immunogenicity
objectives and was well-tolerated with an overall safety profile
generally comparable to PNEUMOVAX®23 (Pneumococcal Vaccine
Polyvalent) across age groups. In the Phase 2 part of the study,
V116 demonstrated non-inferior immune responses to PNEUMOVAX 23 for
all shared serotypes, and superior immune responses for the
serotypes included in V116 but not included in PNEUMOVAX 23, based
on study-defined criteria. Responses were measured 30 days
post-vaccination by serotype-specific opsonophagocytic activity
(OPA) geometric mean titers (GMTs), a measure of functional
antibody activity.
Data from V116-001, in addition to other data from the company’s
pneumococcal vaccines portfolio, are being featured at the
International Symposium on Pneumococci and Pneumococcal Diseases
(ISPPD-12) taking place in Toronto from June 19-23, 2022. The full
study results from V116-001 will be published in a scientific
journal in the future.
Earlier this year, V116 received Breakthrough Therapy
Designation from the U.S. Food and Drug Administration (FDA) for
the prevention of invasive pneumococcal disease (IPD) and
pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes
3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20,
22F, 23A, 23B, 24F, 31, 33F, 35B in adults 18 years of age and
older. This includes eight serotypes not included in any currently
licensed pneumococcal vaccine.
"Our encouraging data at ISPPD reflect the potential of V116 and
Merck’s tailored approach to developing pneumococcal vaccines to
meet the specific needs of different populations,” said Dr. Eliav
Barr, senior vice president, head of global clinical development
and chief medical officer, Merck Research Laboratories. “Consistent
with our portfolio strategy, V116 is designed to specifically
target serotypes that are responsible for 85 percent of all
invasive pneumococcal disease in individuals aged 65 and over in
the United States as of 20191. Importantly, the eight serotypes in
V116 that are not included in any currently-licensed pneumococcal
vaccine account for over 30 percent of this disease burden
alone.1”
Pneumococcal disease is an infection caused by the bacterium
Streptococcus pneumoniae, or pneumococcus. Invasive forms of
pneumococcal disease (IPD) can cause serious and potentially
life-threatening infections such as bacteremia (infection in the
bloodstream) and meningitis (infection of the coverings of the
brain and spinal cord). Pneumonia (infection in the lungs), with or
without bacteremia, also can occur. While healthy adults can suffer
from pneumococcal disease, patient populations particularly
vulnerable to infection include adults 65 years of age and older
and those with certain chronic or immunocompromising health
conditions.
About V116-001
V116-001 is a two-part, randomized, comparator-controlled,
double-blind Phase 1/2 study that assessed the safety, tolerability
and immunogenicity of a single dose of V116 in healthy adults who
have not previously received any pneumococcal vaccine.
In the Phase 1 part of the study, adults aged 18 to 49 years of
age (n=90) were randomized 1:1:1 to receive either a single dose of
V116-1 (2 µg dose/each Pneumococcal polysaccharide (PnPs)), V116-2
(4 µg dose/each PnPs), or PNEUMOVAX 23. Pneumococcal
serotype-specific OPA was measured prior to, and 30 days
postvaccination (Day 30). Immune responses at Day 30 in the V116-1
and V116-2 groups were generally comparable to PNEUMOVAX 23 for the
serotypes common to both vaccines and higher than PNEUMOVAX 23 for
the serotypes unique to V116. At Day 30, the OPA GMTs were higher
in the V116-2 group compared to the V116-1 group for all serotypes
except 9N. The Phase 1 safety and immunogenicity data supported the
continued development of V116 for the prevention of pneumococcal
disease in adults.
In Phase 2, adults aged 50 years or older (n=508) were
randomized 1:1, stratified by age (50-64 years, 65-74 years, and 75
years or older), to receive either a single dose of V116 (4 µg
dose/each PnPs) or PNEUMOVAX 23. Pneumococcal serotype-specific OPA
and Immunoglobulin G (IgG) were measured prior to, and 30 days
postvaccination (Day 30). V116 met noninferiority criteria compared
to PNEUMOVAX 23 for all shared serotypes and met superiority
criteria for the unique serotypes based on assessment of the lower
bound of the GMT ratios, using study-defined thresholds.
Safety was evaluated based on the proportion of participants
with adverse events following vaccination. In both parts of
V116-001, V116 was well-tolerated with an overall safety profile
generally comparable to PNEUMOVAX 23.
Indication for PNEUMOVAX 23 (Pneumococcal Vaccine
Polyvalent)
PNEUMOVAX 23 is a vaccine indicated for active immunization for
the prevention of pneumococcal disease caused by the 23 serotypes
contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A,
11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F).
PNEUMOVAX 23 is approved for use in persons 50 years of age or
older and persons aged ≥2 years who are at increased risk for
pneumococcal disease.
PNEUMOVAX 23 will not prevent disease caused by capsular types
of pneumococcus other than those contained in the vaccine.
Select Safety Information for PNEUMOVAX 23
PNEUMOVAX 23 is contraindicated in individuals with a history of
a hypersensitivity reaction to any component of PNEUMOVAX 23.
Do not administer PNEUMOVAX 23 to individuals with a history of
a hypersensitivity reaction to any component of the vaccine.
Defer vaccination with PNEUMOVAX 23 in persons with moderate or
severe acute illness.
Use caution and appropriate care in administering PNEUMOVAX 23
to individuals with severely compromised cardiovascular and/or
pulmonary function in whom a systemic reaction would pose a
significant risk.
Available human data from clinical trials of PNEUMOVAX 23 in
pregnancy have not established the presence or absence of a
vaccine-associated risk.
Since elderly individuals may not tolerate medical interventions
as well as younger individuals, a higher frequency and/or a greater
severity of reactions in some older individuals cannot be ruled
out.
Persons who are immunocompromised, including persons receiving
immunosuppressive therapy, may have a diminished immune response to
PNEUMOVAX 23.
PNEUMOVAX 23 may not be effective in preventing pneumococcal
meningitis in patients who have chronic cerebrospinal fluid (CSF)
leakage resulting from congenital lesions, skull fractures or
neurosurgical procedures.
The most common adverse reactions, reported in >10% of
subjects vaccinated with PNEUMOVAX 23 for the first time in a
clinical trial, were: injection-site pain/soreness/tenderness,
injection-site swelling/induration, headache, injection-site
erythema, asthenia and fatigue, and myalgia.
For subjects aged 65 years or older in a clinical study,
systemic adverse reactions which were determined by the
investigator to be vaccine-related were higher following
revaccination than following initial vaccination.
Vaccination with PNEUMOVAX 23 may not offer 100% protection from
pneumococcal infection.
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 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 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 Annual
Report on Form 10-K for the year ended December 31, 2021 and the
company’s other filings with the Securities and Exchange Commission
(SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for PNEUMOVAX 23 at
http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf
and Patient Information for PNEUMOVAX 23 at
http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_ppi.pdf.
1Centers for Disease Control and Prevention, IPD serotype data
2019, as compiled from data provided through Active Bacterial Core
surveillance (ABCs).
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