Aimmune Therapeutics’ Pivotal Phase 3 PALISADE Trial of AR101 Meets Primary Endpoint in Patients With Peanut Allergy
AIMMUNE THERAPEUTICS (AIMT)
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Source: Business Wire
Landmark 554-patient Phase 3 study met the primary efficacy endpoint, as 67.2% of AR101 patients ages 4–17 tolerated at least a 600-mg dose of peanut protein in the exit food challenge, compared to 4.0% of placebo patients (p The lower-bound of the 95% confidence interval (CI) of the difference between treatment arms at the primary endpoint was 53.0%, greatly exceeding the pre-specified threshold of 15% (p 50.3% of AR101 patients ages 4–17 tolerated a 1000-mg dose of peanut protein in the exit food challenge, compared to 2.4% of placebo patients (p Among patients ages 4–17 who completed treatment with AR101, 96.3% tolerated a 300-mg dose of peanut protein in the exit food challenge, 84.5% tolerated a 600-mg dose, and 63.2% tolerated a 1000-mg dose 79.6% of AR101 patients ages 4–17 completed the trial; of the 20.4% who discontinued treatment, 12.
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