Aimmune Therapeutics Inc. (NASDAQ: AIMT) shares initially made a handy gain on Tuesday after the company reported data from its late-stage peanut allergy trial, but they quickly turned negative as the morning went on. Even though the company met its primary endpoint for its pivotal Phase 3 PALISADE efficacy trial of AR101, it was not enough for investors.
24/7 Wall St. previously mentioned Aimmune in its FDA calendar for the month of February. A few other companies are reporting data and could see a move later this month as well.
In the Aimmune study, the corresponding difference in response rates was 63.2%, and, at 53%, the lower bound of the 95% confidence interval greatly exceeded the prespecified success criterion.
Additionally, 50.3% of AR101 patients tolerated a single highest dose of 1000 mg of peanut protein, compared to 2.4% of placebo patients. In order to minimize the risk of assessment bias, the primary endpoint evaluations were conducted by independent, blinded assessors, who were not involved in patients’ ongoing care in the trial and who were blinded to treatment assignment and the sequence of the double-blind, placebo-controlled food challenge (DBPCFC).
A. Wesley Burks, M.D., executive dean and Curnen Distinguished Professor of Pediatrics, University of North Carolina School of Medicine, and a principal investigator for PALISADE trial, commented:
It’s exciting to see this large-scale study confirm that a characterized approach to oral immunotherapy, in an appropriately supervised clinical setting, holds promise for becoming an approved treatment. It’s great to have patients go from managing to tolerate at most the amount of peanut protein in a tenth of a peanut without reacting to successfully eating the equivalent of between two to four peanuts with nothing more than mild, transient symptoms, if any at all. Patients and their families are highly motivated to pursue an effective treatment for peanut allergy, and AR101 could give them a comfortable margin of safety in case of accidental exposures.
Looking ahead, Aimmune expects to submit a Biologics License Application (BLA) for AR101 with the FDA by the end of 2018, followed by a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) in the first half of 2019.
Shares of Aimmune were last seen down about 5% at $35.40, with a consensus analyst price target of $57.11 and a 52-week range of $15.97 to $41.86.