DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in Peanut-Allergic Toddlers

Montrouge, France, June 7, 2022 - DBV Technologies, a clinical-stage biopharmaceutical company, has announced positive topline results from its pivotal Phase 3 EPITOPE trial. The trial assessed the safety and efficacy of Viaskin™ Peanut 250 µg for the treatment of peanut-allergic toddlers aged 1 to 3 years and met its primary endpoint.

67.0% of subjects treated with Viaskin Peanut 250 µg met response criteria at 12 months, compared with 33.5% of subjects in the placebo arm. The pivotal trial met its primary endpoint, with the lower bound of the 95% confidence interval (CI) of the difference between treatment arms being 22.4%, exceeding the pre-specified threshold of 15%.

Safety results were generally consistent with the safety profile of Viaskin Peanut 250 µg observed in children with peanut allergy ages 4 years and older in prior clinical trials. A high treatment compliance rate was observed over the trial duration, with a low rate of discontinuation due to adverse events.

DBV Technologies intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population. The company continues productive dialogue with the U.S. Food and Drug Administration (FDA) on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut-allergic children ages 4 years and older.

The EPITOPE trial enrolled 362 subjects ages 1 to 3 years, with 244 in the active and 118 in the placebo arms. The trial demonstrated a statistically significant treatment effect, with a difference in response rates of 33.4% (95% CI = 22.4% - 44.5%).

In an additional pre-specified efficacy analysis, treatment response was defined as achieving an ED ≥1,000 mg of peanut protein regardless of baseline ED. Using this response criterion, Viaskin Peanut demonstrated a statistically significant treatment effect, with 64.2% of subjects in the Viaskin Peanut arm meeting this treatment responder criterion after 12 months as compared to 29.6% of subjects in the placebo arm.

The EPITOPE safety results were generally consistent with the safety profile of Viaskin Peanut 250 µg observed in children with peanut allergy ages 4 years and older in prior clinical trials. No imbalance in the overall adverse event (AE) rate was observed in the trial between the active and placebo arms.

DBV Technologies plans to present full EPITOPE trial results at future medical congresses as well as submit them for publication in a peer-reviewed journal. The company will host a conference call and live audio webcast to discuss the results.