The trial, called ARTEMIS, demonstrated that the proportion of patients treated with AR101 who could tolerate a 1,000mg dose of peanut protein, was significantly higher than what was seen in the placebo group, after nearly nine months of treatment.
The primary efficacy endpoint of the trial was defined as patients’ ability to tolerate a 1,000mg single dose of peanut protein.
ARTEMIS, which was a randomized, double-blind, placebo-controlled late-stage trial, featured 175 children and adolescents, aged from four to 17 years. The trial was held at 18 sites across France, Germany, Ireland, Italy, Spain, Sweden and the UK.
Patients were subjected to nearly six months of dose escalation followed by a daily therapeutic dose of AR101 at 300mg or placebo for three months, before they were put up for an exit double-blind, placebo-controlled food challenge.
Aimmune said that the median tolerated dose of peanut protein for patients in the AR101-arm improved 100-fold, from 10mg at baseline to 1,000mg at exit. The company also claimed that the trial crossed a 15% lower-bound of the 95% confidence interval (CI) of the difference between the two patient arms for all endpoints by a significant extent.
The safety profile and completion rate noted in ARTEMIS is on par with the results observed in previous clinical trials of the investigational drug, said Aimmune.
Aimmune plans to file AR101’s marketing authorization application (MAA) to the European Medicines Agency (EMA) in mid-2019, which will be based on the positive findings of the ARTEMIS trial.
The US biotech company submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the investigational drug last December, which is currently under review. A decision on the BLA is expected to be taken by the regulator until late January 2020, said the company, which is backed by an equity investment from Nestlé Health Science.
Aimmune president and CEO Jayson Dallas said: “AR101 has the potential to become the first approved therapy for peanut allergy in both the United States and Europe, where up to two percent of children in many countries are affected.
“If approved, AR101 could significantly reduce their risk of severe, potentially life-threatening reactions to peanut exposures and provide peace of mind to them and their families.”