Johnson & Johnson stops mid-stage trial of drug for dengue prevention

HQ Team

October 5, 2024: Johnson & Johnson has discontinued its mid-stage trial, evaluating an antiviral drug, mosnodenvir, for the prevention of dengue.

“The decision to discontinue this study is part of a strategic reprioritization of the company’s communicable diseases research and development portfolio,” according to a company statement.

No safety issues were identified and efficacy data from the study will be available once the final data analyses, which are now underway, are complete.

“Mosnodenvir was shown to be safe and well tolerated in previous Phase 1 and Phase 2a clinical studies,” according to the company statement.

DENV infection

Results from the Phase 2a human challenge study found that the compound induced antiviral activity against dengue (DENV-3) in humans, compared to placebo.

Study investigators were notified of the discontinuation and all participants completed the study per the protocol.

The purpose of this study is to evaluate the prophylactic effect of the investigational drug concerning the prevention of laboratory-confirmed dengue virus (DENV) infection up to the last day of dosing among participants who have no evidence of current DENV infection at baseline.

The trial aimed to include 1,850 people between 16 to 65 years of age, according to a US clinical trials database. It was expected to be completed by May 2025.

Dengue is a virus infection transmitted to humans through the bites of infected female mosquitoes, primarily the Aedes Aegypti mosquito.

Sanofi-Pasteur

About half of the world’s population is now at risk of dengue with an estimated 100 to 400 million infections occurring each year, according to the WHO.

The most common symptoms are high fever, headache, body aches, nausea, and rash. Most will get better in 1–2 weeks. Some people develop severe dengue and need care in a hospital.

Sanofi-Pasteur will stop manufacturing its dengue vaccine for children. The manufacturer is discontinuing the vaccine, citing a lack of demand in the global market to continue production of this vaccine, the Centers for Disease Control and Prevention stated. 

There are two other dengue vaccines either approved or in the late stages of development.