(RTTNews) - DBV Technologies (DBVT) announced that its investigational VIASKIN peanut patch met the primary endpoint in the pivotal Phase 3 VITESSE trial, demonstrating significant desensitization in children aged 4 to 7 years with peanut allergy.
Peanut allergy is one of the most common and potentially life-threatening food allergies in children. Even trace exposure can trigger severe reactions, and families often face constant anxiety about accidental ingestion. Current management relies heavily on strict avoidance and emergency preparedness, leaving a clear unmet need for safe, effective therapies. The VITESSE study was a multicenter, randomized, double-blinded, placebo-controlled trial evaluating daily use of the VIASKIN Peanut Patch over 12 months. The patch delivers peanut protein through the skin, aiming to gradually desensitize the immune system without injections or oral dosing.
Key Results:
•Responder Rate: 46.6% of children in the treatment group were responders at 12 months compared to 14.8% in the placebo group.
•Eliciting Dose Improvements: About 83% of treated children increased their tolerance threshold, versus 48% in the placebo group.
•Safety: The therapy was generally well tolerated, with most adverse events limited to mild, localized skin reactions.
Dr. David Fleischer of Children's Hospital Colorado noted that the patch showed consistent benefit across different patient subgroups, reducing the risk of allergic reactions. DBV's Chief Medical Officer, Dr. Pharis Mohideen, emphasized the potential of a non-invasive, daily therapy that could fit seamlessly into family routines.
Based on these results, DBV Technologies plans to submit a Biologics License Application (BLA) to the U.S. FDA in the first half of 2026. If approved, the VIASKIN Peanut Patch could become the first non-invasive, patch-based therapy for peanut allergy in young children.
DBVT has traded between $3.82 and $26.18 over the past year. The stock closed Friday's session at $20.99, down 2.46%. In premarket trading Monday, the stock is up 1.57% to $21.32.
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