Aimmune has announced the results from its Phase III European clinical trials for AR101, the company’s investigational oral biologic drug designed to help protect patients from severe allergic reactions in case they are accidentally exposed to peanut.
The data show that the proportion of AR101-treated patients who tolerated a 1000mg dose of peanut protein after approximately nine months of treatment was significantly higher than in the placebo group.
Additionally, no cases of anaphylaxis or of eosinophilic esophagitis were observed.
The randomised, double-blind, placebo-controlled phase III clinical trial enrolled 175 children and adolescents between the age of four and 17 years old and consisted of a six months of dose escalation, followed by three months at a daily therapeutic dose of 300mg or placebo.
The latest results build on those from the Phase III PALISADE trial, which showed that 50.3% of AR101-treated patients tolerated a single highest dose of 1000 mg of peanut protein compared to just 2.4% of placebo patients.
“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,” said Jayson Dallas, MD, president and CEO of Aimmune.
He added, “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.”
Based on the results, Aimmune has announced its intention to submit a marketing authorisation application for the drug to the European Medicines Agency (EMA) in mid 2019, and has already filed for US approval.
Around 250,000 children in the UK are thought to have a peanut allergy.