Châtillon, France — December 17, 2025 — Leads & Copy — DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309) announced positive topline results from its Phase 3 VITESSE trial of VIASKIN® Peanut patch in peanut allergic children aged 4-7 years. The study met its primary endpoint, with the lower bound of the 95% confidence interval (CI) of the difference between treatment arms at 24.5%, exceeding the prespecified threshold of 15%.
The company reported that 46.6% of children treated with the VIASKIN® Peanut patch met response criteria at 12 months, compared to 14.8% of children in the placebo arm. Safety results were consistent with the safety profile observed in the VIASKIN Peanut clinical program to date. DBV anticipates a BLA submission in 4-7-year-olds in the first half of 2026.
The achievement of the primary endpoint triggers an acceleration of the exercise period of certain warrants issued pursuant to DBV’s March 2025 financing. DBV will host a conference call today at 5:00 p.m. ET to discuss the VITESSE topline results and path forward.
VIASKIN Peanut demonstrated a statistically significant treatment effect (p<0.001)*, with 46.6% of children in the VIASKIN Peanut arm meeting the treatment responder criteria after 12 months, compared to 14.8% of children in the placebo arm (difference in response rates = 31.8%; 95% CI = (24.5, 39.0%)), exceeding the lower bound prespecified threshold of 15%.
Responders were defined as children with a baseline eliciting dose (ED) ≤30 mg who achieved an ED ≥300 mg of peanut protein at month 12, or a child with a baseline ED = 100 mg who achieved an ED ≥600 mg of peanut protein at month 12, as measured by a double-blind, placebo-controlled food challenge (DBPCFC). The ED is the amount of peanut protein that induced an allergic reaction.
David Fleischer M.D., Professor of Pediatrics at Children’s Hospital Colorado and Global Principal Investigator of the VITESSE study, stated that the topline results show a statistically significant treatment effect in children treated with the VIASKIN Peanut patch and that the levels of desensitization achieved in this study after one year on treatment are highly clinically meaningful.
VITESSE enrolled 654 children, exceeding its original enrollment target of 600, of which 438 and 216 were randomized to the active and placebo arms, respectively. Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms. Rates of enrollment in the VITESSE open-label extension were in line with previous VIASKIN Phase 3 studies.
The most common treatment-emergent adverse events (TEAEs) observed during the VITESSE study were mild-to-moderate local skin reactions at the patch application site. Discontinuations due to TEAEs were low at 3.2% in the treatment arm compared to 0.5% of in the placebo arm. There were no reports of treatment-related serious adverse events and treatment-related anaphylaxis was low at 0.5% (n=2). Overall, compliance was high at 96.2%.
Cherie Zachary M.D., President of the American College of Allergy, Asthma and Immunology, is excited to see what’s possible with this innovative treatment in 4-7-year-old patients, if approved, and looks forward to open-label results in the future to fully understand the potential impact VIASKIN Peanut can have in this age group.
DBV is moving forward with plans for a Biologics License Application (BLA) submission in the United States in the first half of 2026.
Daniel Tassé, Chief Executive Officer of DBV Technologies, stated that VITESSE is the largest immunotherapy clinical trial ever conducted in food allergy and that he is looking forward to submitting the BLA to the FDA, as planned, in the first half of 2026.
The FDA previously granted Breakthrough Therapy Designation for VIASKIN Peanut patch, and the Company expects the BLA may be eligible for priority review.
DBV management will host an investor conference call and webcast today, Tuesday, December 16th, at 5:00pm ET, to discuss the VITESSE results and next steps for the program. A live webcast of the call will be available on the Investors & Media section of the Company’s website.
As a result of this announcement of positive VITESSE topline results, the ABSA Warrants and BS Warrants are exercisable through January 15, 2026.
DBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309).
VITESSE (NCT05741476) enrolled 654 children randomized 2:1 to receive either VIASKIN Peanut patch or placebo. The study was conducted at 86 sites across the United States, Canada, United Kingdom, Europe, and Australia. Following the 12-month double-blind period, children were given the option to continue into an open-label extension where all participants receive VIASKIN Peanut patch for up to a total of three years on treatment.
DBV plans to present the full VITESSE results at future medical congresses as well as submit them for publication in a peer-reviewed journal.
Jonathan Neely, DBV Technologies, jonathan.neely@dbv-technologies.com
Brett Whelan, DBV Technologies, brett.whelan@dbv-technologies.com
Source: DBV Technologies
