Phase III PALISADE trial of AR 101 meets primary endpoint in patients with peanut allergy.- Aimmune Therapeutics.

Aimmune Therapeutics announced that its pivotal Phase III PALISADE efficacy trial of AR 101 met the primary endpoint in patients with peanut allergy. PALISADE enrolled 499 patients ages 4�17, 496 of whom received treatment. After approximately one year of treatment, patients completed an exit double-blind, placebo-controlled food challenge (DBPCFC). In the primary analysis of 496 patients ages 4�17, 67.2% of AR101 patients tolerated a single highest dose of at least 600 mg of peanut protein (1043 mg cumulative) with no more than mild symptoms in the exit DBPCFC, compared to 4.0% of placebo patients. The corresponding difference in response rates was 63.2%, and, at 53%, the lower bound of the 95% confidence interval greatly exceeded the pre-specified success criterion, which was 15%.

Additionally, 50.3% of AR101 patients tolerated a single highest dose of 1000 mg of peanut protein (2043 mg cumulative), 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 DBPCFCs. In the trial�s primary analysis group of ages 4-17, 496 patients from both arms (372 AR101 and 124 placebo) were evaluable for safety. In both arms, the incidence of serious adverse events (SAEs) was low. A total of 10 patients experienced SAEs, none of which were considered life-threatening: nine of these patients were in the AR101 arm (2.4%) and one was in the placebo arm (0.8%). In the United States, AR101 has FDA Breakthrough Therapy Designation for peanut-allergic patients ages 4�17.