Aimmune Therapeutics (AIMT) Announces Full Results of its Pivotal Phase 3 European ARTEMIS Trial of PALFORZIA Published in The Lancet Child & Adolescent Health

Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that complete results from its pivotal phase 3 European ARTEMIS trial (AR101 Trial in Europe Measuring Oral Immunotherapy Success) of PALFORZIA® [Peanut (Arachis hypogaea) Allergen Powder-dnfp] have been published in The Lancet Child & Adolescent Health. ARTEMIS met all primary, secondary and safety endpoints, and demonstrated that participants treated with PALFORZIA (known as AR101 outside of the United States) experienced a high degree of desensitization to peanut with an increasingly well-understood, anticipated, and manageable safety profile over nine months. Additionally, improvements in quality-of-life measures in PALFORZIA-treated participants were reported, most notably in how treatment affected the perceived likelihood of future accidental exposure and risk of severe reactions.

ARTEMIS is the third of three randomized, double-blind, placebo-controlled phase 3 trials within the PALFORZIA development program. The three trials comprise the largest clinical dataset in children and teens with peanut allergy and are the only phase 3 clinical trials to meet their primary endpoints.

“The results from ARTEMIS demonstrated that more than half of patients treated with PALFORZIA were able to tolerate the equivalent of approximately seven peanuts after only nine months of treatment and exhibited a safety profile consistent that seen in with our previously reported PALISADE trial. Additionally, there were clear improvements in self- and caregiver proxy-reported quality-of-life measures,” said Daniel Adelman, M.D., Chief Medical Officer of Aimmune Therapeutics. “The publication of this data set, which is included in our marketing authorization application in Europe, underscores our commitment to transparency and to contributing toward the collective understanding of advancing the field of food allergy worldwide.”

The manuscript, entitled “Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial,” is published online and can be accessed through the following link: https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(20)30234-0/fulltext

Key findings include:

• PALFORZIA-treated participants who tolerated a single 1,000 mg peanut protein dose (2,043 mg cumulative, equivalent to approximately seven peanut kernels) in the double-blind, placebo-controlled food challenge (DBPCFC) after nine months of treatment was significantly higher than in the placebo group (intention-to-treat: 58% vs. 2%; p<0.0001).
• In the intention-to-treat analysis, 68% and 74% participants treated with PALFORZIA tolerated the 600 mg and 300 mg exit DBPCFC doses, respectively, compared with 9% and 16%, respectively, of placebo-treated participants (p<0.0001 for both comparisons).
• The safety profile of PALFORZIA was consistent with previous PALFORZIA studies with the frequency and severity of allergic reactions as expected for an oral desensitization therapy. Over 98% of patients in both treatment arms experienced at least one adverse event. Adverse events most frequently affected the gastrointestinal tract, respiratory system, and skin, as has been observed in other peanut OIT trials. No severe systemic allergic reactions or cases of eosinophilic esophagitis were reported. In addition, use of epinephrine in the PALFORZIA arm was less that of the PALISADE phase 3 trial, potentially reflecting cultural differences in the use of epinephrine between the U.S. and Europe. Specifically, epinephrine/adrenaline use was reported in 7% of AR101 treated participants versus 2% of placebo, all for mild/moderate reactions and lower than reported in PALISADE. The PALFORZIA-treated participants were significantly less likely to develop severe symptoms at any challenge dose during the exit peanut DBPCFC, compared with these placebo-treated participants.
• PALFORZIA-treated participants (self-reporting for ages 8-12, 13-17) and their caregivers (proxy reporting for children 4-17 years) recorded greater improvements in quality-of-life measures compared to the placebo group, as assessed via the Food Allergy Quality- of-Life Questionnaires (FAQLQs) and the Food Allergy Independent Measure (FAIM).

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.

PALFORZIA is not approved in Europe, where Aimmune’s marketing authorization application for AR101 is under review with the European Medicines Agency (EMA). The Swiss Agency for Therapeutic Products (SwissMedic) review of AR101 also is ongoing.

About the ARTEMIS Study

ARTEMIS (AR101 Trial in Europe Measuring Oral Immunotherapy Success) evaluated the efficacy and safety of AR101 in 175 peanut-allergic participants aged 4 to 17 years who were enrolled at 18 sites in seven European countries (France, Germany, Ireland, Italy, Spain, Sweden and the United Kingdom). Study participants represented a highly allergic population with a high prevalence of comorbidities who reacted to low doses of peanut protein at screening DBPCFC. The primary endpoint was the patient’s ability to tolerate at least a 1,000 mg single dose of peanut protein (2,043 mg cumulative, equivalent to approximately seven peanut kernels) without dose-limiting symptoms when given the DBPCFC.

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