Aimmune Therapeutics announced that the Phase 2 study of a novel investigational oral immunotherapy (AR101) for the treatment of peanut allergy met its primary endpoint of tolerating a cumulative amount of peanut protein of at least 443mg. The results were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2015.
The ARC001 study was conducted at eight U.S. sites to evaluate the safety and efficacy of AR101 in peanut-allergic patients aged 4–21 who failed a double-blind, placebo-controlled food challenge (DBPCFC) of ≤100mg of peanut protein. A total of 55 patients were randomized to 20 weeks of gradually increasing doses of AR101 and two weeks of maintenance doses or placebo. The exit DBPCFC dose progression was 3mg, 10mg, 30mg, 100mg, 300mg, and 600mg, with the 300mg dose corresponding to the cumulative dose of 443mg and the 600mg dose corresponding to the cumulative dose of 1,043mg.
Of the 23 patients in the treatment arm who completed the study, 100% met the primary endpoint of tolerating a cumulative amount of at least 443mg of peanut protein vs. nearly 20% of those receiving the placebo. Of the patients taking AR101, 78% were able to tolerate exposure of at least 1,043mg cumulative amounts of protein.
Those who completed the study are now eligible to participate in an open-label study designed to evaluate the long-term safety, efficacy and tolerability of AR101.
For more information visit Aimmune.com.