Phase III data shows meaningful desensitization by Aimmune's Palforzia

USA-based biotech Aimmune Therapeutics, which is now fully owned by Swiss foods giant Nestle (NESN: VX), today announced the publication of new clinical data from a pooled analysis of three controlled Phase III (PALISADE, RAMSES, ARTEMIS) and two open-label extension trials (ARC004, ARC011) of Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] in the Journal of Allergy and Clinical Immunology (JACI).

These results, which represent the largest safety data analysis of a single oral immunotherapy (OIT) formulation for peanut allergy, showed a consistent and manageable safety profile with continued Palforzia treatment. The manuscript, titled “Safety of Peanut (Arachis hypogaea) Allergen Powder-dnfp in Children and Teenagers with Peanut Allergy: A Pooled Summary of Phase III and Extension Trials,” was also published  online.

Palforzia was approved as an oral immunotherapy (OIT) for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut for patients aged four to 17 years with a confirmed diagnosis of peanut allergy on January 31, 2020 by the US Food and Drug Administration (FDA), on December 17, 2020 by the European Commission (EC), on April 7, 2021 by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK., and on May 4, 2021 by Swissmedic.