NEJM paper buoys Aimmune’s peanut allergy drug prospects

Results from Aimmune’s phase 3 trial of oral immunotherapy AR101 for peanut allergy have been published and bode well for the program’s planned FDA filing next month. The PALISADE study shows that children who were classed as highly allergic to peanuts were able to tolerate a much higher exposure to peanut protein after treatment with AR101—a 12% defatted peanut flour preparation—at gradually escalating doses up to a threshold of 300 mg per day. By the end of the 550-patient study, 67% of patients were able to tolerate eating 600 mg of peanut protein, compared to 4% of the placebo group.
To put that in perspective for children and their parents, one peanut contains around 250 to 300 mg of peanut protein, so two-thirds of the AR101-treated patients should be able to eat three or four whole peanuts without suffering an allergic reaction, while at the start of the study their tolerance was around half a peanut.