VE202 in Patients with Mild-to-Moderate Ulcerative Colitis

KEY INCLUSION CRITERIA

1. 18 to 75 years of age

2. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization

3. Active mild to moderate UC, as defined by the following:

4. Disease that extends at least 15 cm from the anal verge

5. A modified Mayo score of 4 to 8 with: (i.) Mayo endoscopic subscore of ≥ 2 based on screening flexible sigmoidoscopy; (ii.) Rectal bleeding score of ≥ 1

6. Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC

7. If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization

8. Doses of other allowable UC medications must be stable for at least 8 weeks before randomization

KEY EXCLUSION CRITERIA

1. Known history of Crohn's disease (CD) or indeterminate colitis

2. A known diagnosis of primary sclerosing cholangitis

3. Allergy to VE202 or any of its components

4. Allergy to vancomycin or any of its components

5. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization

6. Use of probiotics or herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of food products such as yogurt, kefir, kombucha, and herbal teas is permissible)

7. Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization

8. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)

9. Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer