Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

This is an international, multicenter, randomized, double-blind, placebo-controlled study of
the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy
regimen in peanut-allergic individuals.

Key Inclusion Criteria:

- Age 4 through 55 years

- Clinical history of allergy to peanuts or peanut-containing foods

- Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific units
per liter, determined by UniCAP™* within the past 12 months) and/or a skin prick test
(SPT) to peanut ≥3 mm compared to control

- Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut
protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in
accordance with PRACTALL** guidelines

- Not be residing at the same address as another subject in this or any peanut OIT study

UniCAP™*: a laboratory system for routine diagnostic testing of allergy and tool for basic
studies on allergens and antibodies

PRACTALL**: PRACTical issues in ALLergology Joint United States/European Union Initiative

Key Exclusion Criteria:

- 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 DBPCFC

- History of chronic disease (other than asthma, atopic dermatitis, or allergic
rhinitis) that is, or is at significant risk of becoming, unstable or requiring a
change in chronic therapeutic regimen

- 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, urticarial pigmentosa, and
hereditary or idiopathic angioedema

- Developing dose-limiting symptoms in reaction to the placebo part of the Screening
DBPCFC

- Having the same place of residence as another subject in the study