DBV Technologies announced positive topline results from the VITESSE Phase 3 trial of VIASKIN Peanut Patch for children aged 4-7 years.
46.6% of children treated with VIASKIN Peanut patch met response criteria at 12 months compared to 14.8% in the placebo arm.
Safety results were consistent with previous observations in the VIASKIN Peanut clinical program.
Primary Endpoint Met
VITESSE met its primary endpoint with a difference between treatment arms of 24.5%, surpassing the threshold of 15%.
Treatment Responder Rate
46.6% of VIASKIN Peanut patch-treated children met response criteria at 12 months, highlighting the treatment's efficacy.
BLA Submission
BLA submission for 4-7-year-olds is on track for the first half of 2026, representing a significant milestone for DBV Technologies.
- The study demonstrated a statistically significant treatment effect of VIASKIN Peanut patch in peanut-allergic children aged 4-7 years.
- Enrollment exceeded the target, with encouraging safety and efficacy results.
- The positive topline results may impact the future management of peanut allergies, offering hope for a non-invasive treatment option.
The successful VITESSE trial results mark a significant advancement in the treatment of peanut allergies in children, potentially offering a transformative therapy option. DBV Technologies continues to show promising progress in the field of allergy treatment.