DBV Technologies (DBV) Status Update summary

Regulatory alignment and accelerated approval pathway

• Achieved formal alignment with FDA on an accelerated approval pathway for Viaskin Peanut in toddlers aged 1–3, with written confirmation received from the agency.

• FDA agreed that efficacy data from the EPITOPE phase 3 study can serve as an intermediate clinical endpoint for accelerated approval.

• Post-marketing confirmatory study criteria and design elements, including double-blind placebo-controlled food challenge and statistical success criteria, have been finalized, with initiation required at BLA submission.

• Separate BLAs will be submitted for toddlers (original patch) and children 4–7 (modified patch), each supported by dedicated phase 3 efficacy and safety studies, with BLA submissions anticipated in the second half of 2026.

• FDA and DBV agreed on key design elements for the COMFORT Toddlers study, including study size and methodology, with study initiation planned for Q2 2025.

Clinical development and study design

• COMFORT Toddlers is a Phase 3, double-blind, placebo-controlled study enrolling ~480 subjects (3:1 randomization), with 360 on active treatment, a six-month primary phase, and optional 18-month open-label extension.

• The study will focus on safety as the primary endpoint and collect adhesion data as an exploratory endpoint, with practical data collection methods agreed upon to minimize burden on families and sites.

• The post-marketing confirmatory study will be initiated at BLA submission, use the commercial patch, and apply the same efficacy criteria as EPITOPE.

• VITESSE phase 3 trial in 4–7-year-olds has completed enrollment (654 subjects), with top-line data expected in Q4 2025.

• COMFORT Children safety study will enroll ~250 subjects, aiming for a total of ~600 on active treatment in this age group.

Product and manufacturing updates

• The commercial Viaskin Peanut patch, modified for easier application and identification, is being used in ongoing and future pivotal and confirmatory trials.

• No clinically relevant differences in efficacy or safety have been observed between the commercial and clinical patches.

• Manufacturing process and location changes were required to scale up production for commercialization.