Chicago, Illinois (October 20, 2023) – The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced today promising data from a Phase 2a human challenge study evaluating JNJ-1802, a first-in-class oral antiviral in development for the prevention of dengue. The data showed that the compound induced antiviral activity against dengue (DENV-3) in humans, compared to placebo, and is safe and well-tolerated. The data were announced at the American Society of Tropical Medicine & Hygiene Annual Meeting in Chicago, Illinois.
JNJ-1802 is the first antiviral to show such activity in humans during a clinical trial. The compound has advanced to a community-based field study to establish efficacy against circulating dengue serotypes in a real-world setting. The study is being conducted in 30+ sites in 10 countries, including Philippines, Thailand, Peru, Brazil and Colombia.
“Climate change threatens to put more people at risk of dengue, yet the world lacks the necessary tools to combat this significant health challenge,” said Ruxandra Draghia-Akli, M.D., Ph.D., Global Head, Global Public Health R&D at Janssen Research & Development, LLC. “For over a decade, we have been committed to following the science to bring forward new solutions for dengue and this new data is an encouraging step forward to addressing the expanding impact of climate change on human health.”
The two-center, randomized, double-blind, placebo-controlled human challenge study evaluated the antiviral activity, safety and pharmacokinetics of different dosing regimens – low, medium or high – of JNJ-1802 against an attenuated dengue 3 serotype (DENV-3) in healthy adults. All participants received daily doses of JNJ-1802 or a placebo over 26 days, during which they were challenged with DENV-3 on day 5. All participants were monitored over 85 days. The study found dose-dependent antiviral effect on the detectability of DENV-3 RNA and time to first onset of detectable DENV-3 RNA compared to placebo and was safe and well-tolerated.
“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 around the world in advancing the development of this compound to its next phase.”
This study follows data published in Nature in March 2023, which showed that JNJ-1802 provides strong protection against dengue in non-human primates and mice, and a Phase 1 first-in-human clinical study showing that the antiviral was safe and well-tolerated.
Janssen thanks its supporting partners including the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Clinical Research (DCR and Office of Clinical Research Policy and Regulatory Operations (OCRPRO) for their collaboration in conducting this trial.
A New Tool to Fight a Growing Threat
The development of a dengue antiviral is critically important to global health. Over half the world’s population currently lives in areas where dengue is endemic. Dengue fever impacts at least 400 million annually, sickening an estimated 100 million and killing thousands, with more going undiagnosed or misdiagnosed.
Changes in climate are exacerbating the crisis, lengthening the infection season and allowing the mosquito that carries the virus to spread beyond its native regions. In 2023, countries like Bolivia, Peru and Bangladesh have already reported some of their worst outbreaks on record, and countries like the U.S., Spain and France are seeing a rise of locally acquired cases for the first time.
Research and development (R&D) against dengue has proven challenging due to four globally circulating serotypes and there are currently no therapeutics and only two licensed vaccines limitedly available. Investment in antivirals, which do not require cold chain and can induce immunity in just days, is sorely needed to diversify the prevention toolbox to slow down outbreaks and limit epidemic-levels of cases.
Johnson & Johnson’s Commitment to Dengue
Johnson & Johnson has been investing in dengue R&D for over a decade. The Company is also collaborating closely with academic partners to bolster local R&D. In June 2022, Johnson & Johnson launched its Satellite Center for Global Health Discovery at Duke-NUS in Singapore, which is focused on accelerating early-stage discovery research to address the growing challenge of flaviviruses, including dengue.
These efforts are part of Johnson & Johnson’s more than 15-year legacy working to address the burden of neglected tropical diseases (NTDs), a group of about 20 communicable diseases that together 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.
You can learn more about our 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 & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at @JanssenUS and @JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
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 Janssen Research & Development, LLC, Janssen Pharmaceutica NV 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 1, 2023, 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 Janssen Research & Development, LLC, Janssen Pharmaceutica NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.