DBV's peanut allergy therapy misses in Phase III

DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said Viaskin Peanut (DBV-712) missed the primary endpoint in the Phase III PEPITES trial to treat peanut allergy in patients ages 4-11.

In the double-blind, international trial, Viaskin Peanut given for 12 months significantly improved response rate vs. placebo (35.3% vs. 13.6%, p=0.00001), but the lower bound of the 95% CI for the response rate difference (12.4%, 29.8%) did not reach the 15% threshold required to meet the primary endpoint under the trial’s proposed statistical analysis plan submitted to FDA. Response was defined as a peanut protein eliciting dose of ≥300 mg in patients with a baseline eliciting dose of ≤10 mg, or a peanut protein eliciting dose of ≥1,000 mg in patients with a baseline eliciting dose >10 mg. The company said it is discussing the data with FDA and still plans to prepare a BLA submission...