Aimmune Therapeutics announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AR101, an oral immunotherapy for children and adolescents 4–17 years of age who are allergic to peanuts.

Aimmune Therapeutics recently announced positive results of ARC001, its randomized, double-blind, placebo-controlled Phase 2 study of AR101 for desensitization treatment of peanut allergy. Results demonstrated that 100% of patients who completed the active treatment regimen (n=23) tolerated exposure to a cumulative amount of at least 443mg of peanut protein, and 78% of those patients tolerated exposure to a cumulative amount of 1,043mg of peanut protein.

AR101 is a complex mixture of naturally occurring proteins and pharmaceutical-grade inactive ingredients designed to enable the dosing of consistent amounts of peanut protein with well-defined concentrations of peanut allergens. Patients ingest AR101 mixed with a common, age-appropriate food.

The company plans to initiate a Phase 3 confirmatory registration trial of AR101 for the desensitization treatment of peanut allergy in children and adults.

For more information visit Aimmune.com.