DBV Technologies, a late-stage biopharmaceutical company, recently announced positive topline results from the Vitesse trial of its Viaskin® peanut patch for the treatment of peanut-allergic children aged 4 to 7 years. The trial met its primary endpoint, with 46.6% of children treated with the Viaskin® peanut patch meeting response criteria at 12 months, compared to 14.8% of children in the placebo arm. This represents a statistically significant treatment effect, with the difference in response rates exceeding the prespecified threshold of 15%, at 31.8%.
The trial, which enrolled 654 children, exceeded its original enrollment target of 600. Safety results were consistent with the safety profile observed in the Viaskin peanut clinical program to date, with mild-to-moderate local skin reactions at the patch application site being the most common treatment-emergent adverse events. Discontinuations due to adverse events were low at 3.2% in the treatment arm compared to 0.5% in the placebo arm, and there were no reports of treatment-related serious adverse events.
DBV Technologies plans to submit a Biologics License Application (BLA) to the FDA in the first half of 2026, with the expectation that the BLA may be eligible for priority review. This follows the FDA's previous grant of breakthrough therapy designation for the Viaskin peanut patch.
The achievement of the primary endpoint has triggered an acceleration of the exercise period of certain warrants issued pursuant to DBV’s March 2025 financing, with the exercise period extended through January 15, 2026.
Dr. David Fleischer, the global principal investigator of the Vitesse study, expressed excitement over the results, highlighting the statistically significant treatment effect and the clinically meaningful desensitization achieved in the study.
Dr. Daniel Tassé, CEO of DBV Technologies, acknowledged the significance of the clinical evidence supporting the Viaskin peanut patch and expressed gratitude to the FDA, clinical investigators, and study participants for their contributions to the program.
The company is moving forward with its plans for the BLA submission and will be hosting an investor conference call and webcast to discuss the Vitesse results and next steps for the program.
DBV Technologies, headquartered in Châtillon, France, with North American operations in Warren, NJ, is focused on 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 and its ADSs are traded on the Nasdaq Capital Market. Following these announcements, the company's shares moved -2.19%, and are now trading at a price of $17.89. For more information, read the company's full 8-K submission here.
