VIASKIN Peanut Patch Shows Strong Desensitization in Phase 3 Trial, With David Fleischer, MD

New phase 3 data presented at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in Philadelphia highlight the potential of the VIASKIN peanut patch, DBV Technologies’ epicutaneous immunotherapy containing 250 µg of peanut protein (1/1000th of 1 peanut kernel), as a practical, noninvasive option for children with peanut allergy. In the phase 3 VITESSE trial, the largest food allergy immunotherapy study to date, 82.8% of children receiving this peanut patch (VP250) increased their eliciting dose over 12 months.

“[With] that increase in eliciting dose, we know it's working,” David Fleischer, MD, professor of pediatrics at Children’s Hospital Colorado and global principal investigator of the VITESSE trial, told HCPLive during the meeting. “Hopefully, it translates into protection from peanut allergic reactions.”

The study, conducted across 87 sites in Australia, Canada, Europe, and the US, sought to assess the efficacy and safety of VP250 in peanut-allergic children aged 4 – 7 years (baseline peanut eliciting dose ≤ 100 mg, psIgE > 0.7 kUA/L, and a skin prick test ≥ 6 mm). Children were randomized to receive either VP250 (n = 438; 60.5% males; mean age, 5.7 years) or placebo (n = 216; 65.7% males; mean age, 5.7 years).

VITESSE met its primary endpoint, with 46.3% of treated children (baseline eliciting dose of ≤ 30 mg) classified as responders compared with 14.7% in the placebo group (P <.0001). Among children with a baseline eliciting dose of 100 mg, 43.1% were responders versus 14.6% in the placebo group. Beyond that primary outcome, most patients experienced measurable improvement: approximately 82.8% increased their eliciting dose over 12 months (versus 48% on placebo), and 60% improved by ≥ 2 dose levels during food challenge testing (versus 23.4% on placebo).

Unlike oral immunotherapy, which requires strict dosing protocols and activity restrictions, epicutaneous immunotherapy offers a simplified approach. The VIASKIN peanut patch delivers a small, fixed dose of allergen through the skin, without the need for dose escalation, dietary timing considerations, or limitations on exercise or illness.

Fleischer said the ease of use helps with adherence rates, which exceeded 96% in the trial. The safety profile remained favorable, with most treatment-emergent adverse events being mild, localized skin reactions. Serious adverse events were rare, and rates of treatment-related anaphylaxis were low.

Nearly 4 times as many children in the placebo arm experienced a decline in their eliciting dose over the study period compared to the patch arm (24% vs 6.4%). This finding reinforces the natural history of peanut allergy, which rarely resolves spontaneously.

“Only about 20% outgrow peanut allergy, and it shows that patients can get worse in the sense that their reaction threshold can lower over time,” Fleischer said. “It's all the importance in starting these therapies early…If only 1 in 5 outgrow it, we want to definitely try to protect these patients…we may be able to get them to the point where they can eat peanut[s] freely in their diet. That's the ultimate goal with these therapies.”

DBV Technologies has indicated plans to submit a Biologics License Application to the FDA in 2026.

Relevant disclosures for Fleischer include DBV Technologies, ARS Pharmaceuticals; UpToDate, Bryn Pharma, Aquestive Therapeutics, Nasus, and Genentech, and Grow Happy.

References

DBV Technologies Highlights Additional Data from Successful Phase 3 VITESSE Study at the AAAAI 2026 Annual Meeting. DBV Technologies. Published February 28, 2026. Accessed March 20, 2026. https://dbv-technologies.com/press_releases/dbv-technologies-highlights-additional-data-from-successful-phase-3-vitesse-study-at-the-aaaai-2026-annual-meeting/