DBV Technologies (NASDAQ: DBVT) Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study

On January 8, 2025, DBV Technologies, a clinical-stage biopharmaceutical company, reported encouraging findings from its EPITOPE Phase 3 Open-Label Extension Study. The study, evaluating VIASKIN Peanut’s efficacy in toddlers aged 1 to 3 years, showcased sustained treatment benefits over 36 months.

According to the results, 68.2% of subjects successfully completed the oral food challenge without meeting stopping criteria, compared to 30.7% at month 12. Additionally, there were no treatment-related anaphylaxis or serious adverse events recorded in the third year of the study. The data revealed continued improvement in treatment response and reductions in reaction severity.

Furthermore, DBV Technologies introduced new daily patch wear time data supporting the proposed labeling strategy for VIASKIN Peanut shared with the FDA in June 2024. This analysis suggested that subjects with consistent daily wear times showcased a more robust efficacy response at 12 months.

These findings were presented at the Eastern Food Allergy and Comorbidity Conference, held from January 9-12, 2025, in Palm Beach, Florida. Key results highlighted the positive impact of continued VIASKIN Peanut treatment, with a significant portion of subjects achieving substantial milestones in the study.

Moreover, DBV Technologies emphasized the importance of average daily wear time in guiding treatment decisions. Subjects with higher daily wear time variability demonstrated improved efficacy responses, indicating the potential for tailored treatment approaches based on patch adherence.

The company reassured stakeholders about the promising trajectory of VIASKIN Peanut and its potential to revolutionize peanut allergy treatment. Dr. Pharis Mohideen, Chief Medical Officer at DBV Technologies, underscored the significance of these results for patients at risk of severe allergic reactions.

DBV’s management hosted an investor webcast on January 8, 2025, at 5:00 pm EST to discuss these clinical updates. Investors and stakeholders were provided with insights on the recent data and the implications for the future of peanut allergy treatment.

DBV Technologies remains committed to advancing innovative therapies for food allergies and addressing significant unmet medical needs. The company’s dedication to improving the lives of patients with severe allergies underscores its mission to transform allergy care significantly.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read DBV Technologies’s 8K filing here.

DBV Technologies Company Profile

DBV Technologies SA, a clinical-stage biopharmaceutical company, engages in the research and development of epicutaneous immunotherapy products. Its product pipeline comprising Viaskin Peanut, an immunotherapy product, which has completed Phase 3 clinical trial for the treatment of peanut allergies; and Viaskin Milk which is in Phase 1/2 clinical trial for the treatment of immunoglobulin E (IgE) mediated or cow’s milk protein allergy and eosinophilic esophagitis.