J&J bites back against dengue, linking antiviral to protection from infection in challenge trial
20 Oct 2023
Phase 2VaccineClinical Result
Preview
Source: FierceBiotech
The data follow a series of changes to the JNJ-1802 development strategy.
One of the last drugs standing at Johnson & Johnson’s slimmed-down infectious disease unit has come through another test. The oral candidate, JNJ-1802, induced antiviral activity against dengue in a human challenge study, offering the Big Pharma encouragement as it works toward data in a larger community-based trial.
J&J has taken an ax to its infectious disease and vaccine operations this year, merging the two units and dropping a clutch of drug candidates. JNJ-1802, a molecule designed to block interactions between two dengue virus proteins, survived the cull and moved into a 1,850-subject, placebo-controlled phase 2 trial early this year.
The company already shared a glimpse of the promise of the molecule in a Nature paper in March. Now, it's using the American Society of Tropical Medicine & Hygiene Annual Meeting in Chicago this week to announce additional data on the candidate.
J&J’s latest data come from a phase 2 trial that randomized healthy volunteers to receive daily doses of JNJ-1802 or placebo for 26 days. Investigators exposed the subjects to dengue virus serotype 3 (DENV-3) on Day 5 and monitored them for 85 days. The study showed a dose-dependent antiviral effect on the detectability of DENV-3 RNA and time to first onset of detectable DENV-3 RNA.
The data follow a series of changes to the JNJ-1802 development strategy. J&J terminated one clinical trial, citing the effect of COVID-19 on enrollment, and paused recruitment in another study last year. But the Big Pharma also showed its commitment to the candidate by starting to enroll 1,850 participants at sites in countries including Brazil, Colombia and Thailand.
The countries selected for the study reflect the fact that dengue is primarily found in South America and parts of Asia. Most cases in people from the U.S. are acquired while traveling outside of the country. However, there are signs that climate change is redefining the area affected by the mosquito-borne disease, with a model suggesting cases in France will rise from 65 last year to more than 3,000 by the end of the decade.
Similar trends could play out in other European countries including Italy and Spain and in parts of the U.S., suggesting the market for JNJ-1802 could extend beyond people traveling to and living in countries in South America and Asia.
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