DBV Technologies Concludes VITESSE Trial Screening for Viaskin Peanut Patch
Key Insights
DBV Technologies completed screening for its VITESSE Phase 3 trial, surpassing recruitment goals for peanut-allergic children aged 4-7.
The VITESSE trial, evaluating the Viaskin Peanut Patch (search), is the largest immunotherapy study for this patient group, spanning 86 global sites.
Topline data from the VITESSE trial, assessing the safety and efficacy of Viaskin Peanut Patch (search), is anticipated in Q4 2025.
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT) has announced the completion of patient screening for the Phase 3 VITESSE trial, designed to evaluate the Viaskin Peanut Patch (search) in children aged 4 to 7 with peanut allergies. The company exceeded its recruitment targets in Q3 2024, allowing for an earlier-than-anticipated conclusion to the screening process.
The VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) trial is a 12-month study assessing the efficacy and safety of the Viaskin Peanut Patch (search) in over 600 subjects randomized in a 2:1 ratio. The trial is being conducted across 86 sites in the U.S., Canada, Europe, the UK, and Australia.
Management Commentary
"We are thrilled to have reached this significant milestone," stated Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. "VITESSE is by far the largest immunotherapy clinical trial for this patient population. I cannot thank our study centers enough for their dedication and commitment to DBV’s Viaskin® peanut patch program. Of course, none of this is possible without our subjects and their supportive families. Being in a clinical trial takes a tremendous amount of time, and we are grateful that subjects are willing to make this sacrifice to further treatments in food allergy. I’m delighted that we closed screening in August, a month earlier than anticipated. I am particularly pleased with our success in reaching out to the diverse communities that suffer from peanut allergies in this trial. DBV continues to focus on advancing this important development program to support a Biologic License Application submission. We look forward to continued collaboration with our shared stakeholders as we move ahead."
Viaskin Peanut Patch and EPIT
The Viaskin platform employs epicutaneous immunotherapy (EPIT), delivering microgram quantities of a biologically active compound to the immune system via intact skin. This non-invasive approach aims to modify the individual's allergic response by re-educating the immune system to become desensitized to the allergen.
Looking Ahead
Topline results from the VITESSE trial are expected in Q4 2025. DBV Technologies is focused on advancing the Viaskin Peanut Patch (search) program to support a Biologic License Application submission, with the goal of providing a new treatment option for peanut-allergic children.