Success for ARTEMIS trial in Europe for AR 101 for treatment of peanut allergy

Aimmune Therapeutics, Inc. announced that its phase III European clinical trial of AR 101 for the treatment of peanut allergy, known as ARTEMIS (AR101 Trial in Europe Measuring oral Immunotherapy Success), met its primary efficacy endpoint.

Topline data show that the proportion of AR 101-treated patients who tolerated a 1,000-mg dose of peanut protein (2,043 mg cumulative) in a blinded exit challenge after approximately nine months of AR 101 treatment was significantly higher (p<0.00001) than in the placebo group. Specifically, the median tolerated dose of peanut protein for AR 101-treated patients improved 100-fold, from 10 mg at baseline to 1,000 mg at exit. The trial also greatly exceeded a 15% lower-bound of the 95% confidence interval (CI) of the difference between treatment arms for all endpoints. In addition, the safety profile and completion rate observed in ARTEMIS are consistent with the results seen in previous AR 101 clinical trials. Notably, no cases of anaphylaxis or of eosinophilic esophagitis (EoE) were observed. Aimmune plans to present full results in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress in early June.