DBV Technologies Reports Positive 3-Year EPITOPE Phase 3 Extension Study Results

DBV Technologies, a biopharmaceutical company based in Châtillon, France, has released promising three-year results from its EPITOPE Phase 3 Open-Label Extension Study. This study focuses on the efficacy of the VIASKIN® Peanut patch for toddlers aged 1 to 3 years. Over a 36-month period, the findings suggest a significant improvement in the treatment’s benefits, with 68.2% of the participants successfully completing the oral food challenge, compared to just 30.7% at the 12-month mark. Notably, no instances of treatment-related anaphylaxis or severe adverse events were reported in the third year of the study.

The EPITOPE study included an Open-Label Extension (OLE) where participants, after 12 months in the initial study, could continue with the VIASKIN Peanut treatment for a total of three years. Double-blind placebo-controlled food challenges were conducted annually to assess efficacy and safety. Importantly, the study maintained the blinding of treatment assignments to prevent bias in continuation decisions.

At the conclusion of the 36-month period, significant progress was observed in the treatment group. Of the 266 participants in the OLE, 211 completed the final food challenge. After three years, 83.5% of those receiving the VIASKIN Peanut patch reached an eliciting dose of at least 1000 mg, a notable increase from 64.2% at 12 months. Similarly, the percentage of participants reaching an eliciting dose of at least 2000 mg rose from 37.0% at 12 months to 72.7% at 36 months. Furthermore, there was a marked reduction in the severity of reactions during food challenges, with 66.5% experiencing no or only mild symptoms at the 36-month mark, compared to 40.2% at 12 months.

In terms of safety, no serious treatment-related adverse events or anaphylaxis incidents were reported in the third year. The frequency of local application-site reactions also decreased compared to the previous two years. The data for placebo participants who switched to active treatment in the OLE aligned with the results seen in the active group over 24 months.

DBV Technologies also shared insights on the patch’s daily wear time and its correlation with treatment efficacy. The study identified that consistent daily wear time is a predictor of a more robust treatment response. Participants with less variability in daily wear time showed better efficacy outcomes at 12 months. This information is valuable for informing the company's labeling strategy, which was proposed to the FDA in mid-2024.

In an upcoming presentation at the Eastern Food Allergy & Comorbidity Conference in January 2025, DBV will highlight these findings. The company is also preparing to launch the COMFORT Toddlers supplementary safety study, a crucial step towards filing a Biologics License Application.

DBV Technologies remains committed to advancing its VIASKIN Peanut patch, a groundbreaking approach in the treatment of peanut allergies through epicutaneous immunotherapy. This method aims to desensitize the immune system to allergens using a non-invasive patch that introduces microgram quantities of active compounds through the skin. As the company moves forward, these results contribute positively to the potential future approval and use of this therapy in addressing peanut allergies in young children.