DBV Technologies (DBVT) has announced the completion of the final patient visit in its Phase 3 VITESSE clinical trial, which is evaluating the VIASKIN Peanut patch for the treatment of peanut allergy in children aged 4 to 7 years.
While topline results are still pending, this marks a critical step towards potentially offering a new treatment option for young patients.
The VITESSE trial is a randomized (2:1), double-blind, placebo-controlled Phase 3 study involving 654 children across 86 sites in the U.S., Canada, Europe, the UK, and Australia.
It is currently the largest treatment intervention study ever conducted in the field of peanut allergy for this age group. The trial is designed to assess the safety and efficacy of the VIASKIN Peanut patch, which delivers microgram doses of peanut protein through intact skin using DBV's proprietary epicutaneous immunotherapy (EPIT) technology.
Completing the last patient's final visit brings DBV one step closer to potentially making this patch available to children who need it most.
The VIASKIN Peanut patch aims to build tolerance to peanut protein, offering a non-invasive, daily treatment alternative for children with peanut allergies.
So far, no new safety concerns or unexpected adverse events have been reported. The company continues to monitor safety data as it prepares for the next phase.
DBV Technologies expects to announce topline results in Q4 2025, which could pave the way for regulatory submissions and, eventually, broader access to the treatment.
DBVT has traded in the range of $0.44 - $18 in the last 1 year. The stock closed yesterday's trading at $13.34, down 1.77%.
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