DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years

Core Insights - DBV Technologies announced positive topline results from the Phase 3 VITESSE trial for the VIASKIN Peanut patch, which met its primary endpoint for treating peanut-allergic children aged 4-7 years [1][6] Study Results - VIASKIN Peanut showed a statistically significant treatment effect with 46.6% of children in the treatment group meeting responder criteria after 12 months, compared to 14.8% in the placebo group, resulting in a difference of 31.8% [2][6] - Responders were defined as children who increased their eliciting dose (ED) of peanut protein significantly after treatment, with specific thresholds based on their baseline ED [3] Safety Profile - The safety results were consistent with previous studies, with mild-to-moderate local skin reactions being the most common adverse events; discontinuation due to adverse events was low at 3.2% in the treatment arm [5][6] - No treatment-related serious adverse events were reported, and treatment-related anaphylaxis was low at 0.5% [5] Enrollment and Study Design - The VITESSE study enrolled 654 children, exceeding the target of 600, with a balanced distribution between active and placebo arms [4][6] - The study is noted as the largest immunotherapy clinical trial for food allergies, conducted at 86 sites across multiple countries [16] Future Plans - DBV Technologies plans to submit a Biologics License Application (BLA) for the VIASKIN Peanut patch in the first half of 2026 [6][7] - The achievement of the primary endpoint will accelerate the exercise period of certain warrants issued in connection with a financing announced in March 2025 [6][11] Industry Context - The VIASKIN patch represents a new class of non-invasive treatment aimed at modifying the immune response to food allergens, addressing a significant unmet medical need in pediatric care [12][14]