On the 2026 American Academy of Allergy, Bronchial asthma, and Immunology (AAAAI) Annual Assembly in Philadelphia, DBV Applied sciences offered compelling new information from its Section 3 VITESSE medical trial. The examine assessed the efficacy and security of the Viaskin® Peanut patch, a non-invasive epicutaneous immunotherapy (EPIT) for youngsters aged 4 to 7 with peanut allergic reactions. The outcomes reinforce the patch’s potential as a transformative therapy, exhibiting a big enhance within the quantity of peanut protein contributors might tolerate earlier than experiencing an allergic response.
The VITESSE examine, acknowledged as the most important EPIT trial in peanut allergy up to now, met its main endpoint. In accordance with the information, 46.6% of kids handled with the Viaskin Peanut patch met the factors for therapy response after 12 months, in contrast with 14.8% within the placebo group. This statistically vital distinction exceeded the pre-specified threshold for the examine’s success, confirming the robustness of the therapy’s impact throughout the examined affected person inhabitants.
Probably the most putting highlights from the presentation was the excessive share of kids who noticed an enchancment of their “eliciting dose“—the quantity of peanut protein that triggers a response. Roughly 83% of kids utilizing the patch elevated their eliciting dose by a minimum of one stage throughout a double-blind, placebo-controlled meals problem. Moreover, 60% of the handled group elevated their tolerance by a minimum of two doses, a pointy distinction with the 23% noticed within the placebo group.
The info additionally revealed a regarding development amongst these not receiving the lively therapy. Whereas the handled group confirmed marked enchancment, 24% of kids within the placebo group noticed their eliciting dose lower over the 12-month interval, indicating they’d turn out to be extra sensitized to peanuts. Dr David Fleischer, International Principal Investigator of the VITESSE examine, famous the medical significance of those findings, stating, “The will increase in eliciting dose seen are clinically significant and should mirror a diminished threat of an allergic response. Conversely, almost 4 instances as many kids on placebo noticed their eliciting dose lower, turning into extra sensitized over the twelve-month interval.”
Past efficacy, the trial underscored the protection profile of the Viaskin Peanut patch. The therapy was typically well-tolerated, with nearly all of adversarial occasions being mild-to-moderate pores and skin reactions on the utility web site. These findings are in line with earlier research and help the patch’s design as a user-friendly, daily-wear possibility. Dr Fleischer added that these outcomes “not solely help the VIASKIN Peanut Patch as a possible therapy possibility for peanut-allergic kids, if permitted, but additionally reinforce the significance of prioritizing a proactive therapy for this particular affected person inhabitants.”
DBV Applied sciences views this information as a crucial basis for its upcoming regulatory steps. Pharis Mohideen, MD, Chief Medical Officer of DBV Applied sciences, emphasised the reliability of the outcomes, saying, “We imagine the extra information offered as we speak reveal that the VIASKIN Peanut Patch persistently induced desensitization amongst topics, regardless of examine subgroup or baseline traits.” He additional highlighted the comfort of the expertise, noting that it “would supply caregivers with a non-invasive possibility that matches into every day actions.”
With the profitable completion of the VITESSE Section 3 trial and the presentation of those supplemental findings, DBV Applied sciences is advancing its regulatory technique. The corporate introduced plans to submit a Biologics License Utility (BLA) to the US Meals and Drug Administration (FDA) within the first half of 2026. If permitted, the Viaskin Peanut patch might quickly turn out to be a main software for households looking for to guard younger kids from unintentional peanut publicity.
