DBV Technologies Finishes Screening for VITESSE Phase 3 Trial

DBV Technologies, a clinical-stage biopharmaceutical company based in Châtillon, France, has announced the successful completion of patient screening for its Phase 3 clinical trial, VITESSE. This trial focuses on the evaluation of the Viaskin Peanut Patch in children aged 4 to 7 with peanut allergies. The company exceeded its recruitment objectives and closed the screening process ahead of schedule in August 2024. The primary results from this study are anticipated by the fourth quarter of 2025.

Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies, expressed excitement over achieving this milestone. He emphasized the significance of VITESSE as the largest immunotherapy clinical trial for children within this age group who are allergic to peanuts. Dr. Mohideen extended gratitude to the study centers and participating families for their commitment and efforts toward advancing treatments for food allergies. He highlighted the importance of this development program, which aims to support a Biologic License Application submission and is optimistic about the ongoing collaboration with stakeholders as the trial progresses.

The VITESSE Phase 3 clinical trial is a 12-month study designed to assess the efficacy and safety of the Viaskin Peanut Patch. Over 600 subjects have been enrolled across 86 sites in the United States, Canada, Europe, the United Kingdom, and Australia. This makes VITESSE the most extensive intervention study currently being conducted for peanut allergies.

DBV Technologies specializes in developing treatments for food allergies and other immunologic conditions with significant medical needs. The company's primary focus is on its proprietary technology platform, Viaskin, which addresses food allergies through epicutaneous immunotherapy (EPIT™). This method introduces microgram quantities of biologically active compounds to the immune system via the skin, aiming to desensitize individuals to allergens by leveraging the skin’s immune properties. EPIT represents a new class of non-invasive treatment that seeks to modify the underlying allergy by re-educating the immune system.

DBV Technologies’ commitment to transforming the care of individuals with food allergies is demonstrated by its ongoing clinical trials. The company's food allergy programs include trials for Viaskin Peanut in peanut-allergic toddlers aged 1 to 3 years and children aged 4 to 7 years.

Headquartered in Châtillon, France, DBV Technologies also has operations in Warren, New Jersey. The company’s ordinary shares are traded on segment B of Euronext Paris under the ticker DBV, with the ISIN code FR0010417345. Additionally, DBV's American Depositary Shares (ADSs), each representing one ordinary share, are traded on the Nasdaq Capital Select Market under the ticker DBVT.

DBV Technologies is dedicated to advancing its research and clinical programs to enhance the lives of individuals affected by food allergies. The company continues to engage with the medical community and stakeholders to achieve its goals in innovative allergy treatment solutions.