A Phase III trial assessing Aimmune Therapeutics’ experimental peanut allergy drug AR101 has hit its primary targets.
In the 554-patient trial, 67.2 percent of patients aged four-17 given AR101 tolerated at least a 600mg dose of peanut protein in the exit food challenge, compared to 4 percent of placebo patients.
According to the data, 50.3 percent of AR101 patients tolerated a 1000mg dose compared to 2.4 percent of placebo patients.
On the safety side, it was reported that 2.4 percent of patients in the treatment arm experienced serious adverse events, none of which were considered life threatening, compared with 0.8 percent of those given a placebo.
“It’s exciting to see this large-scale study confirm that a characterised approach to oral immunotherapy, in an appropriately supervised clinical setting, holds promise for becoming an approved treatment,” said A Wesley Burks, executive dean and Curnen Distinguished Professor of Pediatrics, University of North Carolina School of Medicine, and a principal investigator for PALISADE.
“It’s great to have patients go from managing to tolerate at most the amount of peanut protein in a tenth of a peanut without reacting to successfully eating the equivalent of between two to four peanuts with nothing more than mild, transient symptoms, if any at all. Patients and their families are highly motivated to pursue an effective treatment for peanut allergy, and AR101 could give them a comfortable margin of safety in case of accidental exposures.”
Aimmune expects to file AR101 with US regualtors by the end of 2018, followed by submission to the European Medicines Agency (EMA) in the first half of 2019.
Around 250,000 children in the UK are thought to have a peanut allergy.