Resource Data

Aimmune Therapeutics Announces Results of Safety Data Analysis for PALFORZIA

Aimmune Therapeutics announced the publication of new clinical data on PALFORZIA through the largest safety data analysis of a single formulation of oral immunotherapy (OIT) for peanut allergy.

Pooled analysis of 3 phase 3 controlled trials (PALISADE, RAMSES, ARTEMIS) and two open label extension trials (ARC004, ARC011) of PALFORZIA® [Peanut (Arachis hypogaea) Allergen Powder-dnfp] showed a consistent and manageable safety profile for continued treatment.

PALFORZIA has previously been approved by the United States Food and Drug Administration (FDA) as an OIT for the mitigation of allergic reactions, including anaphylaxis that may occur from accidental exposure to peanuts in patients aged 4 to 17 with a confirmed diagnosis of peanut allergy on January 31, 2020.

Across all trials presented in the review, a total of 944 participants received 1 or more doses of PALFORZIA, of whom 770 (83.8%) completed additional dosing phases.

The exposure-adjusted adverse event (AE) rate was highest during the 2-day initial dose escalation (IDE) (272.2 events/person-years of exposure (PYE), n = 944) but then decreased to a rate of 14.9 events/PYE (n=45 at 79-91 weeks of PALFORZIA 300 mg treatment).

Investigators noted that the most commonly reported AEs were exposure-adjusted treatment-related adverse events (TRAEs), primarily respiratory or gastrointestinal in nature.

Across all dosing phases, 497 (52.6%) PALFORZIA-treated participants experienced treatment-emergent adverse events (TRAE) with a CTCAE (Common Toxicity Criteria for Adverse Events) grade of maximum severity of mild (grade 1), and 332 (35.2%) experienced LTAEs with moderate maximum severity (grade 2).

However, fewer participants in the active PALISADE and ARTEMIS groups experienced AEs due to accidental peanut exposure requiring treatment compared to placebo during the maintenance period, and none of the PALFORZIA-treated participants experienced received epinephrine to treat associated AEs after exposure to peanut allergens.

“This study demonstrated clinically significant desensitization to peanut after PALFORZIA treatment, with a consistent and manageable safety profile,” said Stephen Tilles, Head of Global Medical Affairs, Allergy at Aimmune. “The results of this pooled analysis will provide a valuable resource for allergists to facilitate discussions with their patients and caregivers affected by peanut allergy when considering whether treatment with PALFORZIA may be right for them.”