DBV Technologies, a late-stage biopharmaceutical company, has shared positive data from its successful phase 3 Vitesse clinical trial at the American Academy of Allergy, Asthma, and Immunology (AAAAI) 2026 annual meeting. The trial assessed DBV’s Viaskin® peanut patch for the treatment of peanut-allergic children aged 4 to 7 years. Here are the key highlights from the data presented at the meeting:
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Approximately 83% of children treated with the Viaskin® peanut patch increased their eliciting dose at month 12, compared to approximately 48% in the placebo group.
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Approximately 60% of children treated with the Viaskin® peanut patch increased their eliciting dose by at least two doses at month 12, compared to 23% in the placebo group.
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24% of children on placebo decreased their eliciting dose between the baseline and month 12 double-blind, placebo-controlled food challenge, compared to only 6.4% of children treated with the Viaskin® peanut patch.
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The Viaskin® peanut patch was well tolerated, with the majority of treatment emergent adverse events being mild local application site reactions.
The Vitesse study met its primary endpoint, with Viaskin peanut demonstrating a statistically significant treatment effect. 46.6% of children in the Viaskin peanut arm met the treatment responder criteria at 12 months, compared to 14.8% of children in the placebo arm.
The additional data presented at the meeting suggest a broad and consistent treatment effect of the Viaskin® peanut patch, regardless of baseline eliciting dose strata or study population analysis. The increases in eliciting dose seen are clinically meaningful and may reflect a reduced risk of an allergic reaction.
The presentation emphasized that the Viaskin® peanut patch consistently induced desensitization among subjects irrespective of study subgroup or baseline characteristics. If approved, the Viaskin® peanut patch would provide caregivers with a non-invasive option that fits into daily activities.
DBV Technologies is planning to submit a biologics license application to the FDA in the first half of this year based on the presented data.
The company's ordinary shares are traded on segment B of Euronext Paris and the company’s adss are traded on the NASDAQ Capital Market. The market has reacted to these announcements by moving the company's shares 10.53% to a price of $20.78. For the full picture, make sure to review DBV Technologies's 8-K report.
