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Statement on Completion of First-in-Human Trial Evaluating a Dengue-specific Antiviral Compound
Statement on Completion of First-in-Human Trial Evaluating a Dengue-specific Antiviral Compound

Statement attributed to Marnix Van Loock, Lead for Emerging Pathogens, Global Public Health R&D, Janssen Pharmaceutica NV

At the American Society of Tropical Medicine and Hygiene Annual Meeting, the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced the completion of a Phase 1, first-in-human clinical study evaluating a dengue-specific antiviral small molecule, with data from the study showing the antiviral to be safe and well-tolerated in humans. Additional preclinical data demonstrated the antiviral’s favorable safety profile and effectiveness at preventing dengue in mouse and non-human primate models. Janssen is now evaluating the antiviral in Phase 2a clinical studies.

This builds on data recently published in the journal Nature showing that a compound with a novel mechanism of action could potentially prevent and treat all serotypes of the dengue virus, serving as the basis for the development of the antiviral.

This marks an important step forward in assessing our novel dengue antiviral as we accelerate solutions in the fight against dengue. For too long, the complex and diverse nature of dengue posed challenges to the development of new treatment and prevention methods. We are proud to share these findings with the scientific community as there are currently no treatments available for dengue, and only a single vaccine has been licensed.

New advancements are needed to protect people everywhere. Dengue ranks as the world’s most rapidly spreading mosquito-borne virus, with nearly half the global population at risk for infection, and as many as 400 million people infected each year. The incidence of dengue has grown dramatically in recent decades and is expected to impact billions more as the climate warms and the Aedes aegypti mosquito that carries the dengue virus spreads further from its native regions. An August 2021 report from the Intergovernmental panel on Climate Change underscores the urgency of this global health threat and the need for prevention and treatment options, warning that warming temperatures could potentially drive an increase in vector-borne diseases, like dengue, and make it harder to predict outbreaks.

About the Data
The Phase 1 double-blind, randomized, placebo-controlled study was conducted to evaluate the safety, tolerability and pharmacokinetics (PK) of the novel dengue antiviral compound, which is being developed to prevent dengue. Results from the study show that Janssen’s breakthrough compound administered orally as single or multiple doses, was safe and well-tolerated, with no serious adverse events reported. The preclinical results also demonstrated promising safety data and excellent efficacy at preventing dengue virus infection in mouse and non-human primate models, by blocking the interaction between two viral proteins (NS3 and NS4B) that are needed in the replication process of the dengue virus.

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 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.

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