Aimmune Therapeutics has reported that it has met its primary endpoint in a Phase III PALISADE trial, successfully evaluating the safety and efficacy of AR101 for the treatment of patients with a peanut allergy.
PALISADE is a global, randomised 3:1, double-blind, placebo-controlled trial that enrolled 554 peanut-allergic patients aged between four and 49 years of age.
Of the enrolled patients, 499 patients are aged between four and 17 years, with 55 subjects between 18-49 years old.
During primary analysis of the younger age group, 67.2% of AR101 patients tolerated the single highest dose of at least 600mg of peanut protein with no more than mild symptoms in the exit double-blind, placebo-controlled food challenge (DBPCFC), compared with 4% of placebo participants.
Aimmune also noted that 296 patients in the younger age group from the AR101 arm completed the trial, compared to 116 patients from the placebo arm.
The trial found that from the 296 patients, 96.3% tolerated a single highest dose of at least 300mg of peanut protein in the exit DBPCFC, while 84.5% tolerated at least 600mg, and 63.2% were found to have tolerated 1,000mg of AR101.
AR101 had also reportedly reduced symptom severity at each exit DBPCFC dose level, compared to placebo.
In the trial’s primary analysis group of patients aged between four and 17 years, 372 received AR101 and 124 received placebo. Both arms were evaluable for safety and experienced low-level of serious adverse events (SAEs) during the trial.
In the younger age group, 20.4% of AR101 patients and 6.5% of placebo patients discontinued the trial.
In the AR101 arm, 12.4% of patients discontinued as a result of investigator-reported adverse events, while 2.4% of participants in the placebo arm exited early due to investigator-reported adverse events.
The PALISADE trial was conducted across more than 60 clinical sites in the US, Canada, and eight EU countries.