RARITAN, N.J., Dec. 3, 2021 /PRNewswire/ -- The Janssen
Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ)
today announced it will present data from six company-sponsored
studies in support of their respiratory syncytial virus (RSV) adult
vaccine candidate at the Eighth European Scientific Working Group
on Influenza (ESWI) meeting. The cornerstone of Janssen's presence
at ESWI will be a series of presentations detailing findings from
the Phase 2b CYPRESS trial in adults
at increased risk for RSV.
"There is no vaccine or broadly indicated antiviral treatment
available for RSV in older adults, and the threat of RSV remains
critical," said Penny Heaton, M.D.,
Global Therapeutic Area Head, Vaccines, Janssen Research &
Development, LLC. "We are proud to be leading the charge in
developing a potential vaccine to help address unmet need, and look
forward to presenting new data from our Phase 2b CYPRESS study. Topline results showed our RSV
vaccine candidate met its primary and secondary safety and efficacy
endpoints, which is a significant step forward as we continue to
research a preventive option to protect against lower respiratory
tract disease associated with RSV."
In addition to detailed findings from the CYPRESS study, a
late-breaker abstract detailing the humoral immune response
elicited by Janssen's RSV adult vaccine will be presented.
Immunogenicity data from a Phase 1/2a trial of this vaccine will
also be shared.
Data will be showcased at ESWI during the following
timeframes:
Date/Time (All times CEST)
|
Title
|
December 7,
2021
12:00 –
13:45
|
An
Ad26.RSV.preF-based Vaccine is Effective for Prevention of
RSV-mediated Lower Respiratory Tract Disease and Reduces Symptom
Severity in Vaccine Recipients With RSV Infection: A Phase 2b Study
in Older Adults
|
December 7,
2021
12:00 –
13:45
|
Immunogenicity
Evaluation and Regimen Selection of Prophylactic Ad26.RSV.preF
Vaccine Combinations: A Randomized, Double-Blind,
Placebo-Controlled, Adaptive Design Phase 1/2a Study in Adults ≥60
Years of Age
|
December 7,
2021
12:00 –
13:45
|
Safety and
Tolerability of an Ad26.RSV.preF-based Vaccine in a Randomized,
Double-blind, Placebo-controlled, Phase 2b Study in Adults Aged ≥65
Years
|
December 7,
2021
16:00 –
17:45
Late
Breaker
|
Ad26.RSV.preF-based
Vaccine Regimen Induced Antibody Fc-Effector Functions and
Neutralization are Associated With Protection From Respiratory
Syncytial Virus Infection
|
TIME TBD
|
Correlation Between
Patient-reported and Clinician-assessed RSV Symptoms and Case
Definition to Capture Moderate-to-Severe RSV Disease in Adults Aged
≥65 Years: A Randomized, Placebo-controlled, Phase 2b
Study
|
TIME TBD
|
Measurement of
Symptoms in Respiratory Syncytial Virus–Infected Adults: Meaningful
Within-Patient Change Thresholds for the Respiratory Infection
Intensity and Impact Questionnaire (RiiQ)
|
Janssen's RSV vaccine candidate is currently in Phase 3 trials.
The Company announced the initiation of the EVERGREEN study in
October to evaluate its vaccine candidate versus placebo in
approximately 23,000 adults aged 60 years and older throughout
North America and a selection of
countries across Europe,
Asia and the Southern
Hemisphere.
In September 2019, the U.S. Food
and Drug Administration granted Breakthrough Therapy
Designation for Janssen's RSV adult vaccine candidate for the
prevention of lower respiratory tract disease (LRTD) caused by RSV
in adults aged 60 years or older. This was based on clinical data
indicating the potential for substantial improvement compared to
available standard of care on a clinically significant
endpoint(s).
In November 2020, the European
Medicines Agency's Committee for Medicinal Products for Human Use
designated Janssen's RSV adult vaccine candidate as eligible for
the priority medicines (PRIME) scheme based on promising clinical
data and an unmet need for a prophylactic option to prevent RSV in
older adults.
About Respiratory Syncytial Virus (RSV)
Respiratory
syncytial virus (RSV) is a prevalent, highly contagious respiratory
virus and a leading cause of bronchitis, bronchiolitis and
pneumonia, affecting more than 64 million people worldwide in a
typical year. Because the symptoms of RSV can be difficult to
distinguish from influenza or other respiratory infections, such as
COVID-19, many who are infected with RSV remain undiagnosed.
Older adults, young children and those with underlying health
conditions are most at risk. RSV disproportionately impacts adults
over 60 years and high-risk adults over 18 years who are more
likely to develop a LRTD. Between 3-7 percent of older adults (age
60 and older) and 4-10 percent of high-risk adults (age 18 and
older) experience RSV in a typical year.
With no preventive vaccine or effective antiviral treatment
available, RSV remains a major global public health concern and is
a substantial health and economic burden globally.
About CYPRESS (NCT03982199)
CYPRESS (NCT03982199) is
a randomized, double-blind, placebo-controlled Phase 2b trial. The trial enrolled 5,782 participants
(2,891 in each study arm) aged 65 years and older. The participants
were randomized 1:1 prior to the RSV season to receive Janssen's
RSV adult vaccine candidate or placebo. Immunogenicity and safety
assessments were performed in a subset of approximately 200 and 695
participants, respectively. Disease symptoms were collected through
a questionnaire and/or by a clinician's assessment. For further
information, please see:
https://clinicaltrials.gov/ct2/show/NCT03982199.
About EVERGREEN (NCT04908683)
The EVERGREEN study
(NCT04908683) is a randomized, double-blind, placebo-controlled
Phase 3 efficacy study, which aims to confirm the efficacy of the
vaccine candidate in the prevention of reverse transcription
polymerase chain reaction (RT-PCR) confirmed lower respiratory
tract disease (LRTD) caused by respiratory syncytial virus (RSV)
when compared to placebo in adults aged 60 years and older. The
clinical trial is being conducted in countries in North America, Europe, Africa, Latin
America and Asia Pacific.
Trial participants will be randomized to receive either one dose of
active vaccine candidate or placebo. Prior to the following RSV
season, participants who received the active vaccine will be
re-randomized to receive either the active vaccine again, or
placebo. Participants will be followed for at least two RSV
seasons. For further information, please see:
https://clinicaltrials.gov/ct2/show/NCT04908683.
About the Janssen Pharmaceutical Companies of Johnson &
Johnson
At Janssen, we're creating a future where disease
is a thing of the past. We're the Pharmaceutical Companies of
Johnson & Johnson, working tirelessly to make that future a
reality for patients everywhere by fighting sickness with science,
improving access with ingenuity, and healing hopelessness with
heart. We focus on areas of medicine where we can make the biggest
difference: Cardiovascular & Metabolism, Immunology, Infectious
Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary
Hypertension. Learn more at www.janssen.com. Follow us at
@JanssenGlobal.
Janssen Research & Development, LLC is part of the Janssen
Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding
development of a potential preventive vaccine for RSV. The reader
is cautioned not to rely on these forward-looking statements. These
statements are based on current expectations of future events. If
underlying assumptions prove inaccurate or known or unknown risks
or uncertainties materialize, actual results could vary materially
from the expectations and projections of the Janssen Pharmaceutical
Companies, and/or Johnson & Johnson. Risks and uncertainties
include, but are not limited to: challenges and uncertainties
inherent in product research and development, including the
uncertainty of clinical success and of obtaining regulatory
approvals; uncertainty of commercial success; manufacturing
difficulties and delays; competition, including technological
advances, new products and patents attained by competitors;
challenges to patents; product efficacy or safety concerns
resulting in product recalls or regulatory action; changes in
behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
January 3, 2021, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in the company's most
recently filed Quarterly Report on Form 10-Q, and the company's
subsequent filings with the Securities and Exchange Commission.
Copies of these filings are available online
at www.sec.gov, www.jnj.com or on request from
Johnson & Johnson. None of the Janssen Pharmaceutical Companies
nor Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.
Media Contact:
Ashley Georgian
+31 6 1185 8094
AGeorgi3@its.jnj.com
Investor Relations:
Jennifer
McIntyre
+1 732-524-3922
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