Aimmune Therapeutics announced the 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.
ARTEMIS was a European-based randomized, double-blind, placebo-controlled trial and enrolled 175 children and adolescents ages 4 to 17 with peanut allergy. 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 1,000-mg single dose of peanut protein, the equivalent of approximately three to four peanut kernels (2,043 mg cumulative, equivalent to seven or eight peanut kernels). Topline data show that the proportion of AR101-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 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. No cases of anaphylaxis or of eosinophilic esophagitis (EoE) were observed. Based on this data, Aimmune intends to submit a marketing authorization application (MAA) to the European Medicines Agency (EMA) in mid-2019.
About Peanut Allergy
Peanut allergy is one of the most common food allergies. Peanuts are not the same as tree nuts, which grow on trees. Peanuts grow underground and are part of a different plant family, the legumes. For people with food allergies, the immune system mistakes the proteins in some foods – most commonly peanuts, tree nuts, eggs, milk, soy, wheat, fish, and shellfish – as invaders. However, unlike the immune system’s typical reaction to environmental allergies, people who have food allergies can sometimes experience severe or potentially life-threatening reactions. Common symptoms can include hives, swelling, vomiting, abdominal pain, wheezing, breathlessness, or lowered blood pressure.
AR101 is an oral biologic drug designed to help protect patients from severe allergic reactions in case they are accidentally exposed to peanut. It is based on Aimmune’s oral desensitization immunotherapy (CODIT™) approach. The CODIT approach works by gradually increasing doses of AR101 to desensitize patients to peanut over a period of about six months. Afterward, patients continue to take maintenance doses of AR101 in order to maintain desensitization.
A BLA for AR101 was filed with the FDA in December of 2018 and is currently under review.