DBV Technologies Shares Positive Data from Vitesse Clinical Trial

DBV Technologies announced that the company shared additional positive data from the successful Phase 3 Vitesse clinical trial as an oral presentation at the American Academy of Allergy, Asthma, and Immunology, AAAAI, 2026 Annual Meeting, in Philadelphia, PA. The Vitesse study met its primary endpoint whereby Viaskin Peanut demonstrated a statistically significant treatment effect, with 46.6% of children in the Viaskin Peanut arm meeting the treatment responder criteria at 12 months, as compared to 14.8% of children in the placebo arm, exceeding the lower bound prespecified threshold of 15%. Highlights from the data presented at AAAAI 2026: 82.8% of subjects treated with the Viaskin Peanut Patch increased their eliciting dose by at least one dose, or one incremental step in a double-blind placebo-controlled food challenge, at month 12, compared to approximately 48% in the placebo group. 60.1% of the treated subjects increased their eliciting dose by at least two doses of the double-blind, placebo-controlled food challenge at month 12, compared to 23.4% in the placebo group. 24% of subjects on placebo decreased their eliciting dose between the baseline and month 12 double-blind, placebo-controlled food challenge, compared to only 6.4% of treated subjects. All sensitivity analyses were statistically significant with the 95% CI exceeding the lower bound prespecified threshold of 15%, ranging from 22.1% to 27.8%, confirming the robustness of the primary endpoint analysis. In both baseline eliciting dose strata, a significantly greater proportion of children treated with the Viaskin Peanut Patch were treatment responders as compared to the placebo group. The Viaskin Peanut Patch was well tolerated; the majority of treatment emergent adverse events were mild local application site reactions, consistent with DBV's previous Phase 3 studies.