A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)

A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of
LT-02 (delayed release phosphatidylcholine granules; administered orally via 1.6 g BID for
up to 12 weeks) in subjects with active ulcerative colitis who are refractory to a standard
dose of oral mesalamine therapy. Refractory to mesalamine is defined as active disease
despite receiving at least ≥ 2.4g mesalamine (or equivalent dose) for at least 8 weeks with
or without rectal 5-ASA.

Key Inclusion Criteria:

1. Established diagnosis of ulcerative colitis (UC), based on clinical history,
exclusion of infectious causes, and characteristic endoscopic and histologic
findings.

2. Active UC with disease confirmed by endoscopy findings and confirmed by central
reader.

3. A modified Mayo Score 4-10, and with a centrally read endoscopy score activity of ≥ 2
points.

4. Mesalamine (5-ASA) refractory.

Exclusion Criteria:

1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, radiation
colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
diverticular disease associated colitis,

2. Toxic megacolon or fulminant colitis,

3. Prior colon resection,

4. Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile
infection) at screening,

5. Known celiac disease

6. Other inflammatory or bleeding disorders of the colon and intestine, or diseases what
may cause diarrhea or gastrointestinal bleeding

7. History or presence of ischemic heart disease, myocardial infarction, peripheral
arterial disease, ischemic stroke, or transient ischemic attack,

8. Subjects with known hypersensitivity to soy,

9. Treatment with methotrexate, azathioprine, 6-mercaptopurine TNF-alpha-antagonists,
vedolizumab or certolizumab pegol, tacrolimus, or anti-integrin therapy within last 8
weeks prior to screening,

10. Treatment with any (topical or systemic) corticosteroid formulation for the treatment
of IBD within last 7 days prior to endoscopy,

11. Treatment with other investigational drug within last 8 weeks prior to screening,