Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC

This is a Phase 2, Proof of Concept, multicenter, randomized, double-blind,
placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of
GED-0507-34-Levo in subjects with active, mild-to-moderate Ulcerative Colitis.

The study will consist of 3 phases:

- Screening Phase - up to 4 weeks

- Double-blind Placebo-controlled Phase - Weeks 0 to 8

- Follow-up Phase - Week 9

Inclusion Criteria:

- Male or female aged 18 and over at the time of signing the informed consent.

- Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit.

- MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study

- Subjects are required to have a colonoscopy if one has not been performed within 12
months prior to the Screening Visit.

- Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day

Exclusion Criteria:

- Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic
colitis, radiation colitis, or diverticular disease-associated colitis.

- UC restricted to the distal 15 cm or less (eg, ulcerative proctitis).

- Subjects who have had surgery as a treatment for UC or who, in the opinion of the
Investigator, are likely to require surgery for UC during the study.

- Clinical signs suggestive of fulminant colitis or toxic megacolon.

- Evidence of pathogenic enteric infection.

- History of colorectal cancer or colorectal dysplasia.

- Prior use of any TNF inhibitor (or any biologic agent).

- Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.

- Use of budesonide-MMx within the last 8 weeks.

- Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.

- Use of immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate
[MTX]) within 8 weeks of the Screening Visit.