The antiviral is efficacious in non-human
primates, and is safe and well-tolerated in humans
Findings support further clinical development
for prevention and treatment of dengue, which impacts millions of
people today and is poised to threaten many more due to climate
change
Research builds on Johnson & Johnson’s
enduring commitment to beat neglected tropical diseases, including
dengue
The Janssen Pharmaceutical Companies of Johnson & Johnson
(Janssen) announced today the publication of new data in the
journal Nature showing that an early-stage clinical candidate
(JNJ-1802) provides strong protection against dengue in non-human
primates and mice. The first-in-class antiviral, which was shown to
be safe and well tolerated in a Phase 1 first-in-human clinical
study, is now progressing into Phase 2 clinical studies for the
prevention and treatment of dengue.
The new data indicate JNJ-1802 is effective against all four of
the dengue serotypes in mouse models and provides strong protection
against two tested serotypes (DENV-1 and -2) in non-human primates.
These findings build on research published in Nature in 2021 that
first identified the novel mechanism of action from the same
chemical series as JNJ-1802. The mechanism of action prevents the
interaction between two viral proteins (NS3 and NS4B), thereby
stopping the ability of the virus to replicate. A similar mechanism
of action was confirmed for JNJ-1802 with these new data. This new
research, together with Phase 1 first-in-human data showing the
compound to be safe and well-tolerated, is supportive of further
clinical development of JNJ-1802 for both prophylaxis and treatment
of dengue.
“The unprecedented rise in dengue outbreaks throughout the past
years offers a glimpse of what lies ahead as climate change
continues to put more people and communities at risk of dengue,”
said Ruxandra Draghia-Akli, M.D., Ph.D., Global Head, Global Public
Health R&D at Janssen Research & Development, LLC. “We know
an antiviral will be critical to addressing the unmet needs today
and tomorrow, and we are committed to developing our breakthrough
compound to expand the toolset available to prevent and treat
dengue.”
Janssen thanks its strategic partners in the research and
development of its dengue compound, including the KU Leuven Rega
Institute, the KU Leuven Centre for Drug Design and Discovery
(CD3), Department of Virology at the Biomedical Primate Research
Centre, Department of Infectious Diseases at Heidelberg University,
Sealy Institute for Vaccine Sciences at the University of Texas
Medical Branch Health (UTMB), Unité des Virus Émergents at
Aix-Marseille University and the Walter Reed Army Institute of
Research.
The Growing Global Dengue Threat
Dengue is a significant and growing global health challenge. As
many as 400 million people contract the dengue virus each year, and
the resulting illness is one of the leading causes of
hospitalization among children in countries in Latin America and
Asia. Despite the global burden of dengue, and the fact that
reinfection is possible due to the presence of four dengue
serotypes, there are no therapeutics available to treat the disease
and only a limited number of prevention options have been
approved.
“The promising results of JNJ-1802 to date offer the hope that
science will be able to deliver against this threat as more and
more communities are impacted worldwide,” said Marnix Van Loock,
Ph.D., Lead for Emerging Pathogens, Global Public Health R&D at
Janssen Pharmaceutica NV. “Dengue requires global action and we are
proud to collaborate alongside partners here in Europe and around
the world in advancing the development of this compound to its next
phase.”
The dengue challenge is likely to grow in the coming years. In
2022, countries like Singapore, Nepal and Bangladesh experienced
some of their worst outbreaks on record, while non-endemic
countries like France and the United States reported some of their
first, locally-acquired cases, part of a broader trend of
increasing zoonotic outbreaks linked to climate change.
Strengthening Johnson & Johnson’s Enduring Commitment to
Neglected Tropical Diseases (NTDs)
Johnson & Johnson’s work against dengue is one part of a
larger, more than 15-year legacy working to address the burden of
NTDs, a group of about 20 communicable diseases that affect more
than 1.7 billion people in 149 countries around the world. In 2022,
the Company joined the global community to endorse the Kigali
Declaration on Neglected Tropical Diseases, pledging to continue to
donate up to 200 million doses annually of mebendazole through 2025
to tackle intestinal worms and advance novel R&D programs to
discover new medications needed to beat leprosy and dengue.
In addition to developing JNJ-1802, Johnson & Johnson is
working to holistically strengthen R&D for dengue, including
through novel R&D approaches and leveraging emerging
technology.
To support the Company’s clinical development program, Johnson
& Johnson is using artificial intelligence (AI) to forecast
dengue hotspots and build predictive models for dengue incidence to
accelerate trial recruitment and site sourcing. Data from the
project was recently presented at the 2022 Annual Meeting of the
American Society of Tropical Medicine and Hygiene.
Additionally, the Company launched the Satellite Center for
Global Health Discovery at Duke-NUS Medical School in Singapore in
June 2022, which is focused on accelerating early-stage, discovery
research to address the growing challenge of flaviviruses,
including dengue. The Satellite Center, the first to be established
in Asia, was launched as part of the Company’s broader efforts to
expand the global network for R&D and bolster local R&D,
building on a longstanding collaboration with Duke-NUS.
You can learn more about Johnson & Johnson’s efforts to beat
NTDs, including dengue, by visiting JNJ.com/NTDs.
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 and Retina; Immunology; Infectious
Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary
Hypertension.
Learn more at www.janssen.com. Follow us at @JanssenGlobal and
@JanssenUS. Janssen Research & Development, LLC and Janssen
Pharmaceutica NV are part of the Janssen Pharmaceutical Companies
of Johnson & Johnson.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the
foundation of vibrant lives, thriving communities and forward
progress. That’s why for more than 135 years, we have aimed to keep
people well at every age and every stage of life. Today, as the
world’s largest, most diversified healthcare products company, we
are committed to using our reach and size for good. We strive to
improve access and affordability, create healthier communities, and
put a healthy mind, body and environment within reach of everyone,
everywhere. We are blending our heart, science and ingenuity to
profoundly change the trajectory of health for humanity. Learn more
at www.jnj.com. Follow us at @JNJNews.
Cautions Concerning Forward-Looking
Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding dengue fever, flavivirus and neglected tropical diseases.
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 2, 2022, including in the sections captioned “Cautionary
Note Regarding Forward-Looking Statements” and “Item 1A. Risk
Factors,” and in Johnson & Johnson’s subsequent Quarterly
Reports on Form 10-Q and other 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.
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RKruper@its.jnj.com
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