FDA Labels Peanut OIT Treatment “Breakthrough Therapy”
The FDA has recognized Aimmune Therapeutics’ AR101 peanut desensitization treatment as a “breakthrough therapy” – a designation that will speed up development and testing of the oral immunotherapy treatment.
“We are very grateful for the FDA’s recognition of the large impact AR101 could have in reducing the incidence of life-threatening allergic reactions in people with peanut allergies,” said Stephen Dilly, CEO of Aimmune Therapeutics, which was formerly known as Allergen Research Corp.
AR101 is an oral immunotherapy or OIT treatment for peanut-allergic children and teens. In OIT, patients consume tiny, then gradually increasing doses of an allergen, under medical supervision and instruction, over a prolonged period of time.
AR101 is a peanut protein formulation that has been refined over several years. “AR101 is a complex mixture of naturally occurring proteins and pharmaceutical-grade inactive ingredients,” an Aimmune Therapeutics spokesperson explained. It is a powder that is mixed with a food such as applesauce, pudding, yogurt, or mashed potatoes and consumed daily.
The Phase 2 study involved 29 patients and a placebo group. All 23 patients who completed the trial using the powder were able to tolerate exposure to 445 mg of peanut protein, slightly less than two peanuts, by the end of the two months of increasing OIT doses. A majority of patients (78%) were able to tolerate exposure to 1,043 mg, equivalent to about 3 1/2 peanuts.
Five patients dropped out of the study due largely to gastrointestinal side effects or lack of compliance. One patient who didn’t complete it had an anaphylactic reaction, which resolved with epinephrine.
While this treatment won’t lead to allergic patients eating peanut butter on their toast, it is enough to lessen the concerns around cross-contact.
“Our goal is to prevent severe allergic reactions in the event of an accidental exposure to peanut in peanut-allergic individuals who are continuing to adhere to a peanut-avoidant diet and maintaining ready access to an epinephrine auto-injector,” said the spokesperson. “The goal is not to introduce peanut into the diet.”
Allergist Dr. Wesley Burks presented the successful Phase 2 results at the 2015 European Academy of Allergy and Clinical Immunology (EAACI) Congress in Barcelona, which led FDA’s fast-track decision.
AR101 will now heads into a Phase 3 trial, and Aimmune Therapeutics anticipates that it will be a licensed product within three years.