The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy

Peanut allergy is a common problem with no current treatment. Recent studies have shown some
success with oral or sublingual immunotherapy for the treatment of food allergy. Oral
treatment, which requires very high doses, is associated with a small but appreciable risk of
systemic reactions. Sublingual immunotherapy, which utilizes much smaller doses, is safer but
constraints inherent in the available methods of sublingual administration have limited the
utility of this method. Typically sublingual immunotherapy for food allergy has used either
fresh foods or a simple liquid extract. These methods are not optimized for practicality or
dwell duration in the mouth, and, thus far, dosing has been limited by the ability to make
concentrated extracts and by the volume of extract that can be applied to the sublingual
space. This study is being conducted to determine if a dissolving peanut extract film, will
improve efficacy for immunotherapy for peanut allergy.

Inclusion Criteria:

- Age 18 to 50 years

- Provide signed informed consent

- Using appropriate birth control if subject is female and of child bearing age

- Are available for the study duration

Healthy Volunteers Only

- Regularly consume a meal sized portion (5 grams) of peanut at least twice per month
during the proceeding 6 months

Peanut Allergic Subjects Only

- Have a history of symptomatic reactivity to peanut

- Have a positive skin prick test

- Have a positive oral food challenge to peanut at a cumulative dose of less than 1
grams of peanut protein

- Have self-injectable epinephrine available at home

Exclusion Criteria:

- Have a history of severe anaphylaxis to peanut, defined as hypoxia, hypotension or
neurological compromise as a result of ingestion of peanut.

- Have a history of intubation related to asthma

- Are pregnant or lactating

- Have a viral Upper Respiratory Infection (URI) or gastroenteritis within 7 days of
Oral food challenge

- Have pulmonary function tests <80% of predicted (FEV1) or clinical history consistent
with more than moderate persistent asthma

- Are currently taking greater than medium dose inhaled corticosteroid (>500 mcg/day
fluticasone or fluticasone equivalent)

- Are unable to discontinue antihistamines for 5 days for long acting and 3 days for
short acting prior to skin testing or food challenges

- Have used systemic corticosteroids within 4 weeks prior to baseline visit

- Are receiving omalizumab, beta-blocker, Angiotensin Converting Enzyme (ACE) inhibitor
or tricyclic antidepressant therapy. Subjects need to be off omalizumab for 6 months.

- Have history of oral cancer.

- Use oral tobacco (i.e., chew tobacco)

- Have a chronic disease (other than asthma, atopic dermatitis or rhinitis) requiring
therapy (e.g., heart disease, diabetes)

- Have participated in any interventional study for treatment of a food allergy in the
past 12 months

- Have a history of eosinophilic esophagitis

- Have a severe reaction at initial double blind placebo-controlled food challenge,
defined as either:

- Life-threatening anaphylaxis, or

- Reaction requiring hospitalization

Healthy Volunteers Only

- History of any allergy to peanut