Aimmune Therapeutics Announces Safety Data Analysis Results for PALFORZIA

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

The pooled analysis of 3 controlled phase 3 (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 was previously approved by the US Food and Drug Administration (FDA)as an OIT for the mitigation of allergic reactions including anaphylaxis that may occur with accidental exposure to peanut for patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy on January 31, 2020.

Across all the trials featured in the analysis, a total of 944 participants received 1 or more doses of PALFORZIA, with 770 (83.8%) completing 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 exposure (PYE), n=944) but later decreased to a rate of 14.9 events/PYE (n=45 at 79-91 weeks of 300-mg PALFORZIA treatment).

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

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

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

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