Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children

The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™
regimen for approximately 6 months in peanut-allergic children.

Key Inclusion Criteria:

- Age 4 to 17 years, inclusive

- History of physician-diagnosed peanut allergy

- Positive SPT for peanut and elevated psIgE

- Written informed consent from the subject's parent/guardian

- Written assent from the subject as appropriate (per local regulatory requirements)

- Use of effective birth control by sexually active female subjects of childbearing
potential

Key Exclusion Criteria:

- Subjects in whom the clinical diagnosis of peanut allergy is uncertain

- History of cardiovascular disease, including uncontrolled or inadequately controlled
hypertension

- History of severe or life-threatening episode of anaphylaxis or anaphylactic shock
within 60 days of screening

- History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal
disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD),
symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology

- History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic
idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold
urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema

- Any other condition that, in the opinion of the Investigator, precludes participation
for reasons of safety