Vitesse Phase 3 trial met primary endpoint, DBV Technologies reports

DBV Technologies reported that its Phase 3 Vitesse trial of the Viaskin Peanut Patch met its primary endpoint, with 46.6% of treated children meeting responder criteria at 12 months versus 14.8% for placebo; most adverse events were mild local application-site reactions.

DBV Technologies presented additional results from its Phase 3 Vitesse trial of the Viaskin Peanut Patch at the AAAAI 2026 Annual Meeting. The company reported that the study met its prespecified primary endpoint, showing a higher proportion of treatment responders in the Viaskin arm at 12 months compared with placebo. The trial assessed changes in eliciting dose using double-blind, placebo-controlled food challenges in children. The report noted that the patch was generally well tolerated and most treatment-emergent adverse events were mild local application-site reactions. Key results: - 46.6% of children in the Viaskin Peanut arm met the treatment responder criteria at 12 months versus 14.8% in the placebo arm, exceeding the prespecified lower bound threshold of 15%. - 82.8% of treated subjects increased their eliciting dose by at least one incremental step at month 12, compared with about 48% in the placebo group. - 60.1% of treated subjects increased their eliciting dose by at least two doses at month 12, compared with 23.4% in the placebo group. - 24% of subjects on placebo decreased their eliciting dose between baseline and month 12, compared with 6.4% of treated subjects. - All sensitivity analyses were statistically significant with 95% confidence intervals exceeding the prespecified lower bound, reported as ranging from 22.1% to 27.8%. Summary: The reported results indicate that the Vitesse trial met its primary endpoint and showed larger increases in eliciting dose among treated children than placebo. Undetermined at this time.