Aimmune has announced that its Phase III 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 1000-mg dose of peanut protein (2043mg cumulative) in a blinded exit challenge after approximately nine months of AR101 treatment was significantly higher (p<0.00001) than in the placebo group. Specifically, the median tolerated dose of peanut protein for AR101-treated patients improved 100-fold, from 10mg at baseline to 1000mg 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 AR101 clinical trials. Notably, no cases of anaphylaxis or of eosinophilic esophagitis 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.
The ARTEMIS findings reinforce the results from the highest level tested in Aimmune’s landmark Phase III PALISADE trial, which found that 50.3% of AR101-treated patients tolerated a single highest dose of 1000mg of peanut protein (2043mg cumulative) after approximately six months of dose escalation followed by six months at a daily therapeutic dose of 300mg, compared to 2.4% of placebo patients (p<0.00001). Full results from the PALISADE trial were published in November 2018 in the New England Journal of Medicine.
ARTEMIS enrolled 175 children and adolescents ages 4 to 17 from 18 sites in France, Germany, Ireland, Italy, Spain, Sweden and the UK. Patients underwent approximately six months of dose escalation and then three months at a daily therapeutic dose of AR101 at 300 mg or placebo, followed by an exit double-blind, placebo-controlled food challenge. The primary efficacy endpoint was patients’ ability to tolerate a 1000-mg single dose of peanut protein, the equivalent of approximately three to four peanut kernels (2043mg cumulative, equivalent to seven or eight peanut kernels).
Based on these positive results, Aimmune intends to submit a marketing authorisation application for AR101 to the European Medicines Agency in mid-2019.