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

HCPLive 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 (P <.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.

HCPLive: 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.

HCPLive: 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.

HCPLive: 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.

HCPLive: 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.

HCPLive: 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.

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/