J & J Discontinues Study for Investigational Antiviral for Dengue Prevention

Image credit: J & J

Today, Johnson & Johnson announced it was stopping its phase 2 field study that was evaluating its investigational antiviral, mosnodenvir (formerly JNJ-1802). The company said the decision to discontinue this study is part of a strategic reprioritization of the company’s communicable diseases research and development (R&D) portfolio.¹

In previous phase 1 and phase 2a clinical studies, mosnodenvir was shown to be safe and well tolerated. Results from the phase 2a human challenge study found that the compound induced antiviral activity against dengue (DENV-3) in humans, compared to placebo.¹

Efficacy data from the phase 2 field study will be available once the final data analyses, which are now underway, are complete. Study investigators have been notified of the discontinuation. All participants have completed the study per protocol and will be notified of the results once they are ready.¹

According to one report in The Lancet Infectious Diseases, around 90 countries have reported dengue cases this year, with the Americas reporting an all-time high of more than 11 million cases as of September 5, 2024. ²

In the United States, there have been 3,613 locally acquired cases as of October 2 reporting, according to the Centers for Disease Control and Prevention (CDC). The incidence rates of vector-borne diseases in the country continue to rise.³

There is an FDA-approved dengue vaccine, Dengvaxia, which is not approved for use in US travelers visiting but not residing in dengue-endemic areas. Dengvaxia is authorized for children aged 9 to 16 who have previously had a laboratory-confirmed dengue infection and live in regions where dengue is prevalent, including certain US territories and associated states.³

In the US, dengue is considered endemic in US territories of American Samoa, Puerto Rico, and the US Virgin Islands, and freely associated states, including the Federated States of Micronesia, the Republic of Marshall Islands, and the Republic of Palau.⁴

Reference

1. Johnson & Johnson to Discontinue Phase 2 Field Study Evaluating Investigational Antiviral for the Prevention of Dengue. October 4, 2024. Accessed October 4, 2024.
https://www.jnj.com/media-center/press-releases/johnson-johnson-to-discontinue-phase-2-field-study-evaluating-investigational-antiviral-for-the-prevention-of-dengue
2.Venkatesan P. Global upsurge in dengue in 2024. Lancet Infect Dis. 2024;24(10):e620. doi:10.1016/S1473-3099(24)00609-1
3.Current Year Data. Dengue. CDC. October 2, 2024. Accessed October 4, 2024. https://www.cdc.gov/dengue/data-research/facts-stats/current-data.html
4.Dengue Vaccine. CDC.August 12, 2024. Accessed October 4, 2024.
https://www.cdc.gov/dengue/hcp/vaccine/index.html#:~:text=Dengvaxia%20is%20the%20only%20dengue%20vaccine%20approved%20by%20the%20U.S.,all%20four%20dengue%20virus%20serotypes.