David Fleischer, MD, professor of pediatrics at Children’s Hospital Colorado.

David Fleischer, MD

spoke with David Fleischer, MD, professor of pediatrics at Children’s Hospital Colorado, about new data from the 

phase 3 VITESSE trial assessing the effectiveness of VIASKIN peanut patch (VP250)

 for building tolerance and increasing desensitization. The study showed that 82.8% of children who received VP250, compared with 48% on placebo, increased their eliciting dose over 12 months.

VP250, an epicutaneous immunotherapy containing 250 µg of peanut protein (1/1000th of a peanut kernel), is a non-invasive option for children with food allergy. Investigators evaluated the patch in 438 peanut-allergic children aged 4 – 7 years across 87 sites in Australia, Canada, Europe, and the US, compared with 216 controls.

VITESSE met its primary endpoint, with significantly more responding with VP250 versus placebo (46.3% vs 14.7% and 43.1% vs 14.6%) among children with baseline eliciting dose of ≤ 30 mg and 100 mg, respectively (

 <.001). In addition to the favorable response rate, 60% of patients in the VP250 arm, compared with 23.4% on placebo, improved by ≥ 2 dose levels during food challenge testing. The study also showed that children receiving the patch experienced a greater decline in their eliciting dose over the study period compared with those receiving the placebo.

DBV Technologies announced in late February 2026 that it plans to submit a Biologics License Application to the US Food & Drug Administration (FDA) this year.

In this Q&A, Fleischer discusses the clinical significance of these findings and the next steps for research.

How clinically meaningful is the increase in eliciting dose observed with the VIASKIN Peanut Patch, particularly for children with lower baseline thresholds?

It's very important. Imagine being a parent of a food-allergic child and being worried about getting a phone call every day from school or from somewhere else. This really can translate into several peanuts of protection over time. If you get to several peanuts of protection, that's definitely going to translate into something clinically effective for patients… they can feel [assured] that they're not going to get that phone call from school.

What unanswered questions remain following the VITESSE trial?

There's more unanswered questions with respect to food allergy in general. I don't have many questions [about this]. This data continue[s] to show the same data that we've seen with previous studies around the safety, the practicality, and the efficacy of it, that it really works quite well.

We want to look long-term again to show that we get [a] continued effect. One thing that will be studied formally, which we have not looked at with this product, is…sustained unresponsiveness or remission. The idea is where you stop the therapy for a certain period of time, completely avoid peanut[s] in the product…not use it as treatment, and then challenge again to see if there's a sustained effect. We're going to do that for the first time in a large trial to see if there's a sustained effect of this product.

With a biologics license application planned for submission to the U.S. Food and Drug Administration, what milestones should clinicians be watching for as this therapy moves toward potential approval?

That filing is the big milestone that will be that would be a huge one, and then the FDA has a certain period of time to decide that. I can't foresee this product not getting approved. We've proven efficacy, we've proven safety, compliance, [and] practicality.

Can you discuss future research on this topic?

[Future research will] follow the patients over time with peanut allergy to continue to show that, if you continue to use this product.

[The company is] going to start the milk epicutaneous immunotherapy phase 2 trial, I believe, once [the] peanut [trial] moves along. They’re going to continue with other foods, which is exciting, because we need more options for other foods…including milk…egg, and tree nuts. Hopefully, the company will branch out into more foods besides milk.

Is there anything else you would like to highlight about this data?

It's fantastic data to show that epicutaneous immunotherapy, [at] such a low dose, works to desensitize the vast majority of patients to a level that I think will protect them clinically from allergic reactions, and it does it in a way that's extremely easy to be compliant with, which is important when you're using a daily therapy.

If it's not easy, you're not going to do it. If there's a lot of rules around it, it's going to be hard to do. This is almost set it and forget it.

To put [the patch] on, you'll have some skin reactions over time. But from a safety standpoint, the risk of anaphylaxis is 1- 2%, which I think is reasonable, certainly not as high as oral immunotherapy, which could be as high as 15%. I think there's no comparison there. The practicality, safety, and efficacy of this product [are] going to prove that it's going to be a true option that patients and families want to use.

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

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/

Articles

In this Q&A, Fleischer discusses clinically meaningful gains in peanut allergy desensitization, strong response rates, and the path toward FDA submission for VP250.


VIASKIN Peanut Patch Shows Strong Phase 3 VITESSE Results, With David Fleischer, MD

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

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 

. 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 

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 (

 <.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.

Videos

Phase 3 VITESSE data show VIASKIN peanut patch improves tolerance in most children, with high adherence and a favorable safety profile.