DBV Technologies VITESSE Trial Shows 46.6% Responder Rate and 82.8% Dose Increase
DBV Technologies’ Phase 3 VITESSE trial showed 46.6% of peanut-allergic children treated with the VIASKIN Peanut Patch met responder criteria versus 14.8% in placebo (difference 31.8%, 95% CI 24.5–39.0%, p<0.001). 82.8% increased eliciting dose by one and 60.1% by two versus 48.0% and 23.4% in placebo, with only mild local reactions.
1. Primary Efficacy Results
The VITESSE Phase 3 study met its primary endpoint with 46.6% of children treated with the VIASKIN Peanut Patch meeting responder criteria at month 12 compared to 14.8% in the placebo arm, yielding a 31.8% treatment effect (95% CI 24.5–39.0%, p<0.001).
2. Secondary Dose Escalation Data
Additional analyses showed 82.8% of treated subjects increased their eliciting dose by at least one step and 60.1% by two steps, versus 48.0% and 23.4% respectively in the placebo group, indicating robust desensitization across measures.
3. Safety Profile
The VIASKIN Peanut Patch was well tolerated, with most treatment-emergent adverse events limited to mild local application-site reactions, consistent with prior Phase 3 findings and supporting its safety for long-term use.
4. Regulatory Pathway
DBV Technologies plans to submit a Biologics License Application to the FDA in the first half of this year, leveraging these statistically significant and clinically meaningful data to support approval of its non-invasive peanut allergy therapy.