Assessment of KAN-101 in Celiac Disease (ACeD)

Study KAN-101-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of KAN-101 in patients with celiac disease on a gluten free diet (GFD).

An overview of the two parts and proposed dose groups is given below:

• Part A (SAD): Patients will receive a single dose of KAN-101.
• Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.

Key Inclusion Criteria:

• Adults aged 18 to 70 years inclusive
• Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy
• Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)
• Has followed a GFD for > 12 months immediately prior to study entry
• Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening
• Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods
• Capable of understanding and complying with protocol requirements
• Patient understands and has signed the informed consent form

Key Exclusion Criteria:

• Refractory celiac disease
• Selective IgA deficiency
• Positive for HLA-DQ8 (DQA1*03, DQB1*0302)
• Previous treatment with tolerance-inducing therapies for celiac disease
• Known wheat allergy
• Part B only: History of hyperacute or prolonged symptoms following gluten exposure
• Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation
• History of dermatitis herpetiformis
• Pregnant or breastfeeding