APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients with Eosinophilic Esophagitis

The purpose of this program is to provide compassionate use of APT-1011 for adult and adolescent patients
with eosinophilic esophagitis (EoE) who are unable or ineligible to enroll in an APT-1011 clinical study or have failed available treatment options.

The following data will be collected during the program
1. Tolerability and safety of APT-1011
2. Height for adolescent patients
3. Global EoE Scores over time

This expanded access program is an open-label, single-arm design where consenting patients may participate
up until APT-1011 is commercially available in the relevant regions or the protocol is terminated by the
Sponsor.

Patients will receive a 120-day supply of APT-1011 and will attend scheduled clinic visits every 4 months.
Telephone visits will be performed as needed. At each clinic visit (or additional telephone visit), adverse
events (AEs) and concomitant medications will be collected. The Global EoE score will be collected at clinic
visit.

Inclusion criteria:
Male or female ≥12 years of age at the time of informed consent
2. Signed informed consent form (ICF) and willing and able to
adhere to all procedures; signed assent form and parent/guardian
ICF must also be collected for adolescents
3. Confirmed medical history of EoE
4. Adult and adolescent patients who are unable or ineligible to
enroll in an APT-1011 clinical study or have failed available
treatment options
Willing and able to adhere to the treatment regimen and visit
schedule

Exclusion criteria:
Patients will not be included if any of the following apply:
1. Have known contraindication, hypersensitivity, or intolerance to
corticosteroids
2. Have signs and symptoms of adrenal suppression or
hypercorticism
3. Use of potent CYP3A4 inhibitors (e.g., ritonavir and
ketoconazole) are prohibited
4. Have current alcohol or drug abuse in the opinion of the
Investigator
5. Female patients who are pregnant, breastfeeding, or planning to
become pregnant while participating in the program
6. Female patients of child-bearing potential who are unable to
comply with adequate contraception use during the program