French DBV Technologies has completed screening for the VITESSE phase 3 clinical trial In Q3 2024, exceeding its recruitment goal and successfully closed the screening process for the VITESSE Phase 3 study evaluating the Viaskin® Peanut Patch in peanut allergic children ages 4 – 7 years old.
Topline results of VITESSE data are expected by Q4 2025 DBV Technologies, the clinical-stage biopharmaceutical company said Monday, as it announced that patient screening is complete for the Phase 3 trial, VITESSE, using the modified Viaskin Peanut Patch in children ages 4 – 7 years old with peanut allergy.
“We are thrilled to have reached this significant milestone,” said 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.”
The fully enrolled VITESSE Phase 3 trial in peanut-allergic children ages 4 – 7 is a 12-month study evaluating the efficacy and safety of the Viaskin Peanut Patch in more than 600 subjects (randomized 2:1), representing individuals across 86 sites in the U.S., Canada, Europe, the UK, and Australia. VITESSE is currently the largest treatment intervention study in peanut allergy. About DBV TechnologiesDBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need.
DBV is currently focused on investigating the use of its proprietary technology platform, Viaskin, to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children.
Through epicutaneous immunotherapy (EPIT™), the Viaskin platform is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age).