J&J Discontinues Phase II Dengue Study as it Retreats from Infectious Disease

Pictured: J&J's office in Madrid, Spain

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J&J has recently pulled back from the infectious diseases space, including winding down R&D activity in this area in August 2023.

Johnson & Johnson on Friday announced that it was stopping the Phase II field study of its investigational antiviral mosnodenvir for the prevention of dengue.

According to the pharma, the move is part of its “strategic reprioritization” of its communicable diseases portfolio. J&J insists that the discontinuation was not motivated by safety issues, none of which have so far been identified, the company said in its news release.

J&J added that it is currently conducting a full analysis of the field study and will share its findings with participants and the broader scientific community in the future.

Mosnodenvir is an investigational antiviral agent that functions as a pan-serotype inhibitor of the NS4B protein, which dengue viruses use to replicate their genetic material.

J&J had previously begun a Phase IIa, double-blinded and placebo-controlled study of mosnodenvir in patients with confirmed dengue infection, but had to eventually discontinue the trial due to enrollment difficulties linked to the COVID-19 pandemic. The pharma had a third mid-stage trial to assess the antiviral activity, safety and pharmacokinetic profile of repeated mosnodenvir doses against dengue serotype 1. According to the its clinicaltrials.gov page, enrollment into that study has been suspended.

Friday’s announcement comes after J&J announced in mid-2023 that it was scaling back its presence in the infectious disease space. In its second-quarter 2023 business report, the pharma revealed the discontinuation of seven infectious disease programs, including several for hepatitis B, alongside candidates for HIV, influenza and hepatitis D.

A few months earlier, in March 2023, J&J also exited the respiratory syncytial virus vaccine space, discontinuing its Phase III EVERGREEN trial after a review of the competitive landscape. In January 2023, J&J had terminated the Phase III Mosaico trial for its investigational HIV vaccine regimen due to disappointing data, making it the second HIV vaccine study that the pharma dropped in as many years.

J&J continued its strategic shift away from infectious disease in August 2023, noting at the time that it would wind down R&D activity in this space except for a few select programs. The pharma nevertheless said at the time that it would continue to provide its HIV and E. coli vaccines, while work for other infectious diseases, such as dengue and tuberculosis, would be folded into Janssen’s global health portfolio.

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
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