DBV peanut allergy treatment fails Phase III study

DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) plummeted $25.17 (52%) to $22.90 in after-hours trading on NASDAQ Friday after it said Viaskin Peanut (DBV-712) missed the primary endpoint in the Phase III PEPITES trial to treat peanut allergy in patients aged four to 11. Aimmune Therapeutics Inc. (NASDAQ:AIMT), whose competing peanut allergy therapy is in Phase III testing, climbed $11.44 (45%) to $37.10 after hours.

In PEPITES, 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 at least 300 mg in patients with a baseline eliciting dose of 10 mg or less, or a peanut protein eliciting dose of at least 1,000 mg in patients with a baseline eliciting dose greater than 10 mg. The company said it is discussing the data with FDA and still plans to prepare a BLA submission...