Aimmune Therapeutics, Inc. announced new clinical data from a pooled analysis of three controlled phase 3 (PALISADE1, RAMSES, ARTEMIS2) and three open-label extension (ARC0043, ARC008, ARC011) trials of PALFORZIA. In patients with peanut allergy (ages 4 through 17) who continued daily treatment with PALFORZIA for up to 3.5 years reported adverse events were mostly mild, occurred early on in treatment, and declined over the course of treatment. With longer-term treatment, systemic allergic reactions and epinephrine use were rare and continued to decrease with treatment. The findings being presented at AAAAI further build on the full results from ARC004, the open-label follow-on study to the pivotal phase 3 PALISADE trial of PALFORZIA, which were published in the Journal of Allergy & Clinical Immunology: In Practice, on December 31, 2020, and reported that long-term daily dosing with PALFORZIA was well tolerated, with no newly identified safety concerns. Furthermore, the data showed that continued daily treatment with PALFORZIA beyond one year in peanut-allergic patients (ages 4 through 17) resulted in sustained efficacy, was well tolerated with a favorable safety profile, and was associated with changes in blood levels of peanut-specific immunoglobulin E (IgE) and immunoglobulin G4 (IgG4) that suggest ongoing immunomodulation during the second year of treatment with PALFORZIA. High rates of desensitization were also observed, which improved over time; desensitization rates were highest in those receiving daily dosing of PALFORZIA for the longest duration (2 years). These data will be presented online in a poster presentation: #335: “Safety of Peanut (Arachis Hypogaea) Allergen Powder-dnfp in Children and Teenagers With Peanut Allergy: Pooled Analysis From Controlled and Open-Label Phase 3 Trials Over 3.5 Years. Key highlights from the data presentation include: More than 3 out of 4 patients were able to achieve the 300mg maintenance dose of PALFORZIA (n=938), and more than half of all patients had received at least one year of treatment (n=755) as of July 31, 2020; 431 and 94 patients across the studies received 2 and 3 years of PALFORZIA treatment, respectively. Participants reported mild-to-moderate treatment-related adverse events (TRAEs) during the updosing phase (26.2% moderate, 57.9% mild) and decreased throughout the maintenance phase (1.4% moderate, 5.8% mild, at the end of year 3). The most frequently reported TRAEs were throat irritation, abdominal pain, and oral pruritis. Overall, 13.3% of trial patients discontinued participation due to adverse events, with gastrointestinal symptoms as the most common primary reason for withdrawal, most of which occurred during the first 6 months. Exposure-adjusted rates of systemic allergic reactions of any severity and epinephrine use were low during Year 1 and decreased in Years 2 and 3. Over a 3.5-year treatment period, 14 participants (1.2%) experienced a treatment-related severe systemic allergic reaction. PALFORZIA was approved by the U.S. Food and Drug Administration (FDA) in January 2020 as an oral immunotherapy for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy. In December 2020, the European Commission (EC) approved PALFORZIA for patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet. Additionally, a Swiss Agency for Therapeutic Products (SwissMedic) review of AR101 is ongoing. PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older. PALFORZIA is to be used in conjunction with a peanut-avoidant diet.