- DBV Technologies SA's DBVT pivotal Phase 3 EPITOPE trial of Viaskin Peanut 250 µg for peanut-allergic toddlers ages 1 to 3 years met its primary endpoint.
- Viaskin Peanut demonstrated a statistically significant treatment effect, with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, compared to 33.5% of subjects in the placebo arm.
- DBV continues a productive dialogue with the FDA on the Phase 3 VITESSE trial protocol of the modified Viaskin Peanut patch in peanut-allergic children ages four years and older.
- Related: DBV Technologies To Conduct New Pivotal Trial For Peanut Allergy Patch, Shares Plunge To 52-Week Low.
- In an additional pre-specified efficacy analysis, Viaskin Peanut demonstrated a statistically significant treatment effect, with 64.2% of subjects in the Viaskin Peanut arm meeting this treatment responder criterion after 12 months compared to 29.6% of subjects in the placebo arm.
- The safety results were generally consistent with the safety profile of Viaskin Peanut 250 μg observed in children with peanut allergy ages four years and older in prior clinical trials.
- No imbalance in the overall adverse event rate was observed between the active and placebo arms in the trial.
- Price Action: DBVT shares are up 15.03% at $1.53 during the premarket session on the last check Wednesday.
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