Peanut Allergy Patch For Kids? DBV Technologies Advances Toward FDA Filing
DBV Technologies S.A. (NASDAQ:DBVT) on Tuesday released data from the VITESSE Phase 3 study assessing the safety and efficacy of VIASKIN Peanut patch for peanut-allergic children aged 4 to 7 years.
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Trial Data
The pivotal trial met its primary endpoint.
VIASKIN Peanut demonstrated a statistically significant treatment effect, with 46.6% of children in the VIASKIN Peanut arm meeting the treatment responder criteria after 12 months, as compared to 14.8% of children in the placebo arm.
Responders were defined as children with a baseline eliciting dose (ED) ≤30 mg who achieved an ED ≥300 mg of peanut protein at month 12, or a child with a baseline ED = 100 mg who achieved an ED ≥600 mg of peanut protein at month 12, as measured by a double-blind, placebo-controlled food challenge (DBPCFC).
The ED is the amount of peanut protein that induced an allergic reaction.
VITESSE enrolled 654 children, exceeding its original enrollment target of 600, of which 438 and 216 were randomized to the active and placebo arms, respectively.
Safety results were consistent with the safety profile of the VIASKIN Peanut clinical program to date.
The most common treatment-emergent adverse events (TEAEs) observed during the VITESSE study were mild-to-moderate local skin reactions at the patch application site.
Discontinuations due to TEAEs were low at 3.2% in the treatment arm compared to 0.5% in the placebo arm.
There were no reports of treatment-related serious adverse events, and treatment-related anaphylaxis was low at 0.5% (n=2) – both children continued treatment.
The company said data from the exploratory adhesion assessments were in line with its expectations.
Overall, compliance was high at 96.2%, consistent with what has been observed in other Phase 3 VIASKIN Peanut studies.
What Next?
DBV is moving forward with plans for a Biologics License Application (BLA) submission in the United States in the first half of 2026.
DBVT Price Action: DBV Technologies shares were up 35.76% at $24.41 during premarket trading on Tuesday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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