Aimmune Therapeutics Inc (NASDAQ: AIMT) shares rose Monday after the company presented results from its pivotal Phase 3 PALISADE trial of AR101 for peanut allergy at the AAAAI-WAO.
The results, published Sunday, noted 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 four–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 Breakthrough Therapy Designation for peanut-allergic patients ages 4–17, and Aimmune plans to submit a Biologics License Application for AR101 by the end of 2018.
PALISADE (Peanut ALlergy oral Immunotherapy Study of AR101 for DEsensitization in children and adults) was an international, randomized 3:1, double-blind, placebo-controlled, Phase 3 trial of the efficacy and safety of AR101 in a Characterized Oral Desensitization ImmunoTherapy approach in patients with peanut allergy.
PALISADE enrolled 554 peanut-allergic patients ages 4–49 (498 ages 4–17) at more than 60 clinical sites in the United States, Canada, and eight countries in the European Union.
Aimmune Therapeutics, based in Brisbane, Florida, is a clinical-stage biopharmaceutical company developing treatments for potentially life-threatening food allergies.
Shares in Aimmune galloped $1.44, or 4.2%, in Monday’s last hour of trade to $35.51, within a 52-week trading range of $15.97 to $42.00