The candidate proved its effectiveness in treating patients with a severe peanut allergy.
Aimmune Therapeutics, Inc. has released that its candidate AR101, which is backed by an FDA Breakthrough Therapy Designation, has met its endpoints in a Phase 3 PALISADE efficacy trial. AR101 aids in potentially life-threatening peanut allergies for adolescents ages 4-17. The PALISADE study included 499 patients—of those, 496 received treatment. The study took place over the course of a year, in which patients took on an exit double-blind, placebo-controlled food challenge (DBPCFC). Of those patients, 62.7% were able to tolerate a single highest dose of at least 600 mg worth of peanut protein, or 1043 mg cumulative, and experience nothing more than mild symptoms in the exit DBPCFC—in direct opposition to the 4% of placebo patients. Of those on AR101, just over half, 50.3%, were able to tolerate 1000mg of the peanut versus 2.4% of those on a placebo.
The PALISADE trial also included 55 adults aged 18-49; of those, 41 patients were given the AR101, while another 14 patients had a placebo. Of the adult group, 85% of the AR101 patients who completed the study were able to tolerate at least 600 mg of peanut protein at the completion of the DBPCFC, as compared to 15% of placebo patients who completed the study.
Wesley Burks, M.D., Executive Dean and Curnen Distinguished Professor of Pediatrics, University of North Carolina School of Medicine, and a Principal Investigator for PALISADE commented on the promising attributes of the candidate, which he was able to witness first hand. “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,” Burks noted.
Daniel C. Adelman, M.D., Chief Medical Officer of Aimmune also spoke on the trial results and how AR101 has the potential to affect the lives of many. “PALISADE is not only the largest peanut allergy trial ever conducted, it’s also the first to use an independent blinded assessor, and the first to accept peanut-allergic patients with a history of severe or life-threatening reactions. Moreover, the PALISADE population was highly peanut-sensitive and highly atopic, with almost three quarters of the patients having experienced anaphylaxis prior to enrolling in the study. Given how robust the PALISADE results are and that they met or exceeded the pre-specified metrics, we’re very encouraged that the data from PALISADE are helping to define the magnitude of the potential treatment effect in very sensitive peanut-allergic patients,” continued Adelman.
CEO Stephen Dilly, M.B.B.S., Ph.D. took the opportunity to acknowledge those affected by food allergies in this community. “Aimmune was originally founded through the commitment of food allergy parents, food allergy advocates, and food allergy researchers. They all saw a future where a safe, reliable and accessible medicine could protect people from terrifying allergic reactions that occur because of innocent, inevitable mistakes. We remain the custodians of their vision, and we are proud to be taking another meaningful step toward delivering on it,” he said.
Following their endpoint goal, Aimmune will submit a Biologics License Application (BLA) for AR101 with the FDA by the end of this year. The company will then file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA), within the first six months of 2019. PALISADE stands for: Peanut ALlergy oral Immunotherapy Study of AR101 for DEsensitization in children and adults. The study was conducted at over 60 clinical locations in the US and across 8 countries in Europe. AR101 is a novel, investigational oral biologic drug for use in oral immunotherapy (OIT) in patients who have been diagnosed with a peanut allergy.