Aimmune Therapeutics Inc (NASDAQ:AIMT) reported that its pivotal Phase III PALISADE efficacy study of AR101 achieved the primary endpoint. In the U.S., AR101 has U.S. FDA Breakthrough Therapy status for peanut-allergic patients aged 4–17.
- Wesley Burks, M.D., who is a principal investigator for Phase 3 PALISADE trial, expressed that it’s thrilling to see this large-scale trial validate that a characterized plan to oral immunotherapy, in a suitably supervised clinical setting, exhibits promise for becoming a permitted treatment. It’s remarkable to have people go from managing to tolerate maximum quantity of peanut protein in a 10th of a peanut without reacting to well eating the equivalent of between 2 to 4 peanuts with only mild, transient indications, if any at all. Subjects and their families are extremely motivated to follow an effective treatment for peanut allergy. AR101 could provide them a comfortable safety margin in instance of accidental exposures.
Daniel C. Adelman, M.D., the CMO of Aimmune Therapeutics, expressed that they intend to express their heartfelt gratitude to participants who supported the PALISADE study, particularly the investigators and the respective teams, their employees, and, above all, the subjects and their families. PALISADE is the largest peanut allergy study ever carried out. Also, it also marks as the first to utilize an independent blinded assessor, and the preliminary to accept peanut-allergic subjects with a history of life-threatening or severe reactions.
In addition, the PALISADE population was extremely peanut-sensitive and extremely atopic, with nearly three quarters of the subjects having struggled with anaphylaxis prior to registering in the study. Provided how robust the PALISADE trial results are and that they exceeded or met the pre-specified metrics, they are extremely thrilled that the results from PALISADE trial are helping to state the magnitude of the prospective treatment effect in extremely sensitive peanut-allergic patients. The team is enormously delighted with this result.