Aimmune Therapeutics has reported positive results from its Phase III ARTEMIS trial of AR101 for the treatment of peanut allergy.
For the randomised, double-blind, placebo-controlled ARTEMIS clinical trial, Aimmune enrolled 175 children and adolescents aged 4 to 17 from 18 sites in France, Germany, Ireland, Italy, Spain, Sweden and the UK.
Patients underwent about six months of dose escalation and then three months at a daily therapeutic dose of AR101 at 300mg or placebo. This was followed by an exit double-blind, placebo-controlled food challenge.
The primary efficacy endpoint was the patients’ ability to tolerate a 1,000mg single dose of peanut protein.
The study met the primary endpoint of a statistically significant proportion of AR101-treated patients who tolerated the dose in a blinded exit challenge at month nine compared to placebo.
It also exceeded a 15% lower-bound of the 95% confidence interval of the difference between treatment arms for all endpoints.
Aimmune Therapeutics president and CEO Jayson Dallas said: “We are very pleased with the results of the ARTEMIS trial, which demonstrate that AR101 significantly improved the ability of patients to tolerate the 1,000mg dose of peanut protein in the exit food challenge, which correlates to at least three or four peanuts.
“AR101 has the potential to become the first approved therapy for peanut allergy in both the US and Europe, where up to two percent of children in many countries are affected.”
Based on the positive results, Aimmune proposes to submit a marketing authorisation application (MAA) for AR101 to the European Medicines Agency (EMA) this year.
Aimmune started a Phase II trial of AR101 with adjunctive dupilumab in October last year for the treatment of patients with peanut allergies as part of the collaboration with Regeneron and Sanofi.