Aimmune Therapeutics which is a bio pharmaceutical company curating treatments for fatal food allergies, announced that the results of its pivotal Phase 3 PALISADE trial of AR101 for the treatment of peanut allergy.
PALISADE studied the efficacy and safety of AR101 in peanut-allergic patients by assessing reductions in clinical reactivity to peanut. In the primary analysis of patients ages 4–17, the trial met its primary and secondary endpoints, and AR101 demonstrated an encouraging tolerability and safety profile over the course of approximately one year of treatment. AR101 has U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for peanut-allergic patients.
Stacie Jones, M.D., said “Efficacy and Safety of AR101 in Peanut Allergy: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial (PALISADE)” (Oral L6). Expanding on the topline results, today’s presentation included analyses of symptom severity in the exit double-blind, placebo-controlled food challenge (DBPCFC) and of immune modulation as measured by peanut-specific biomarkers.”
PALISADE enrolled a total of 554 patients ages 4-49. After approximately one year of treatment, patients completed an exit DBPCFC. In the trial’s primary analysis of ages 4–17, patients were highly atopic and highly sensitive to peanut. The median tolerated dose of peanut protein in the entry DBPCFC was 10 mg, the equivalent of approximately 1/30 of a peanut, and, at baseline, 43% of patients had a peanut-specific IgE level >100 kU/L. Furthermore, more than half of the study participants had been diagnosed with asthma, nearly two thirds had multiple food allergies, and almost three quarters reported a history of anaphylaxis.