Aimmune European Phase 3 trial of AR101 meets primary endpoint
Aimmune Therapeutics announced that its phase 3 European clinical trial of AR101 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 AR101-treated patients who tolerated a 1,000-mg dose of peanut protein in a blinded exit challenge after approximately nine months of AR101 treatment was significantly higher than in the placebo group. Specifically, the median tolerated dose of peanut protein for AR101-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, or 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 AR101 clinical trials. Notably, no cases of anaphylaxis or of eosinophilic esophagitis, or EoE, were observed. Aimmune plans to present full results in an oral presentation at the European Academy of Allergy and Clinical Immunology, or EAACI, Congress in early June.