Janssen Announces Novel Dengue Antiviral Demonstrates Efficacy in Pre-Clinical Data Published in Nature

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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