VIASKIN Peanut Patch
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DBV Technologies Highlights Additional Data from Successful Phase 3 VITESSE Study at the AAAAI 2026 Annual Meeting
Globenewswire· 2026-02-28 19:25
Core Insights - DBV Technologies presented additional positive data from the Phase 3 VITESSE clinical trial for the VIASKIN Peanut Patch at the AAAAI 2026 Annual Meeting, indicating its potential as a treatment for peanut allergies in children aged 4 to 7 years [2][5] Study Results - The VITESSE study met its primary endpoint, showing a statistically significant treatment effect (p<0.001), with 46.6% of children in the VIASKIN Peanut group meeting treatment responder criteria at 12 months, compared to 14.8% in the placebo group, resulting in a difference of 31.8% [3][6] - Approximately 83% of children treated with the VIASKIN Peanut Patch increased their eliciting dose at month 12, compared to 48% in the placebo group [6][7] - 60% of children treated with the VIASKIN Peanut Patch increased their eliciting dose by at least two doses at month 12, compared to 23% in the placebo group [6][7] - 24% of children on placebo decreased their eliciting dose, while only 6.4% of those treated with the VIASKIN Peanut Patch experienced a decrease [6][7] Treatment Effectiveness - The data suggest a broad and consistent treatment effect of the VIASKIN Peanut Patch across different baseline eliciting dose strata and study population analyses [5] - Among children with a baseline eliciting dose (ED) ≤30 mg, 49.3% were responders versus 14.7% in the placebo group, and among those with a baseline ED = 100 mg, 43.1% were responders versus 14.6% in the placebo group [7] Safety Profile - The VIASKIN Peanut Patch was well tolerated, with most treatment-emergent adverse events being mild local reactions, consistent with previous Phase 3 studies [7] Future Plans - DBV Technologies plans to submit a Biologics License Application (BLA) to the FDA in the first half of the year, supported by the positive data from the VITESSE study [8]