VIASKIN Peanut Patch Demonstrates Statistically Significant Benefit in Treating Peanut Allergy in Young Children

DBV Technologies has announced positive topline results from its pivotal Phase 3 VITESSE trial, showing that the VIASKIN Peanut patch provides a clinically meaningful and statistically significant benefit for peanut-allergic children aged 4-7. These findings are not only promising for families and clinicians managing food allergies, but also set important milestones for DBV's regulatory and financial future.

Primary Endpoint Surpassed: VIASKIN Patch Significantly Outperforms Placebo

The VITESSE study met its primary endpoint, with the lower bound of the 95% confidence interval for the difference in treatment response rates reaching 24.5%, comfortably exceeding the pre-specified threshold of 15%. Specifically, 46.6% of children in the VIASKIN Peanut arm met the response criteria at 12 months compared to just 14.8% in the placebo group. This difference translates to a statistically significant improvement in peanut protein tolerance after one year on the patch (p<0.001).

Safety Remains Consistent and Favorable for Pediatric Use

Safety outcomes in the VITESSE trial mirrored previous clinical studies of the VIASKIN Peanut patch, with no new safety signals detected. The most frequent side effects were mild-to-moderate skin reactions at the application site. Discontinuation due to adverse events remained low (3.2% in the treatment group vs. 0.5% in placebo), and only 0.5% experienced treatment-related anaphylaxis—importantly, both continued in the study. Overall compliance with treatment was exceptionally high at 96.2%.

Pathway to FDA Submission and Financial Acceleration Triggered

Following these results, DBV is on track to submit a Biologics License Application (BLA) in the United States for children aged 4-7 in the first half of 2026. In parallel, this achievement has accelerated the exercise window for previously issued warrants as part of the company’s 2025 financing round, with proceeds that could provide a significant capital boost through January 2026.

Largest Food Allergy Immunotherapy Trial Signals Clinical Progress

VITESSE enrolled 654 children across the US, Europe, and Australia—making it the largest food allergy immunotherapy study to date. Balanced enrollment by age and baseline allergy characteristics, together with strong open-label extension participation, reinforces the clinical robustness of the trial data. Full study details are expected at future medical meetings and through peer-reviewed publications.

Key Takeaways for Investors and Stakeholders

The statistically significant and clinically meaningful efficacy of VIASKIN Peanut patch, paired with a solid safety profile, strengthens DBV’s positioning ahead of regulatory submissions and potentially supports expedited review. The link to a major capital injection via warrant acceleration adds further runway to advance product commercialization—an alignment of clinical and corporate momentum not often seen at this late stage in drug development.

Investors and healthcare providers will want to watch for the full trial data releases, upcoming regulatory submissions, and evolving market implications as DBV navigates this pivotal inflection point in pediatric food allergy therapeutics.

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