Highlights 

  • Final patient visit completed in VITESSE Phase 3 trial of VIASKIN® Peanut patch. 
  • Topline results from the study are expected in Q4 2025. 
  • Trial enrolled 654 children aged 4–7 across 86 sites globally. 

DBV Technologies (NASDAQ:DBVT), a clinical-stage biopharmaceutical company, confirmed the completion of the last patient visit in its Phase 3 VITESSE trial. The study is evaluating the VIASKIN® Peanut patch in peanut-allergic children aged 4–7 years. This double-blind, placebo-controlled trial marks the end of the treatment phase. 

The company remains on track to release topline data from VITESSE in the fourth quarter of 2025. 

Management Comments 

Daniel Tassé, Chief Executive Officer of DBV Technologies, said: “Last patient last visit represents a very important milestone for DBV, as it brings us one step closer to the potential of bringing this treatment option to peanut allergic children, their physicians and caregivers, if approved. We’re grateful to the investigators, internal teams, and most importantly patients and caregivers for their time and commitment to this study. We look forward to sharing topline results this quarter.” 

Study Design and Scope 

The VITESSE trial is a 12-month study assessing the safety and efficacy of the VIASKIN® Peanut patch in 654 participants, randomized 2:1. The trial spans 86 sites across the U.S., Canada, Europe, the UK, and Australia. VITESSE is currently the largest treatment intervention study in peanut allergy targeting children ages 4–7. 

VIASKIN® and Epicutaneous Immunotherapy (EPIT) 

VIASKIN® employs epicutaneous immunotherapy, introducing microgram quantities of allergen through intact skin to modify immune response. EPIT is designed to desensitize the immune system to allergens while avoiding invasive procedures. DBV is exploring VIASKIN® for food allergies, including peanut allergies in toddlers (ages 1–3) and children (ages 4–7), aiming to provide non-invasive treatment options. 

Company Overview 

DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The company develops treatments for food allergies and other immunologic conditions with significant unmet medical needs.