Phase 3 Palisade trial of AR101 met primary endpoint in peanut allergy
Aimmune Therapeutics (AIMT) announced that its pivotal Phase 3 PALISADE efficacy trial of AR101 met the primary endpoint.
In the United States, AR101 has U.S. Food and Drug Administration Breakthrough Therapy Designation for peanut-allergic patients ages 4-17.
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. 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 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, 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.
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