05:25 PM EDT, 06/25/2025 (MT Newswires) -- DBV Technologies ( DBVT ) has begun screening subjects for a phase 3 supplemental safety study evaluating the Viaskin Peanut patch in peanut-allergic children aged 1-3.

The study will supplement the safety and efficacy data from a separate completed phase 3 study in the same population, the company said late Wednesday.

The supplemental trial's results will likely support a biologics license application filing in H2 2026 under the US Food and Drug Administration's Accelerated Approval pathway.

The company plans to enroll roughly 480 participants in 80 to 90 centers across the US, Canada, Australia, the UK, and Europe for the supplemental study.

The trial duration will be six months, followed by an optional 18-month open-label treatment phase, to generate up to 24 or 18 months of active treatment with the patch for participants randomized to the active or placebo groups, respectively.