DBV Technologies (DBV) Study Result summary

Clinical development and regulatory pathway

• Two Viaskin Peanut patches are in development: a square patch for toddlers (1–3 years) and a circular patch for children (4–7 years), each with separate regulatory pathways and planned BLA submissions in the second half of 2026.

• The toddlers' program will use the accelerated approval pathway, supported by completed and upcoming Phase III studies, with a post-market confirmatory study at BLA submission.

• The children’s program includes the ongoing VITESSE trial and a supplemental safety study, with top-line data expected in Q4 2025.

• Viaskin Peanut has Breakthrough Designation and is considered a novel technology targeting Langerhans cells in the skin.

• Company plans to initiate the COMFORT Toddlers supplemental safety study to support BLA submission.

Study design and objectives

• EPITOPE Phase 3 Open-Label Extension (OLE) evaluated Viaskin Peanut patch in toddlers aged 1–3 years over 36 months.

• 266 participants enrolled in OLE after 12 months in the initial EPITOPE study; 211 completed the 36-month food challenge.

• Double-blind placebo-controlled food challenges were conducted annually; safety was monitored throughout.

• All subjects remained blinded to initial treatment assignment until database lock, minimizing bias.

• Study aimed to assess long-term efficacy, safety, and impact of patch wear time on outcomes.

Key efficacy results

• 83.5% of participants reached an eliciting dose (ED) ≥1000 mg at 36 months, up from 64.2% at 12 months.

• 68.2% completed the food challenge (12–14 peanut kernels) without meeting stopping criteria at 36 months, up from 30.7% at 12 months.

• 72.7% reached an ED >2000 mg at 36 months, compared to 37.0% at 12 months.

• Placebo group outcomes after 24 months of active treatment were consistent with those seen in the active group.

• Efficacy improved year-on-year, with about 80% achieving an eliciting dose of at least 1,000 mg and over 70% reaching 2,000 mg.