Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

This is a phase 2, randomized, double-blind, multicenter study to assess the therapeutic efficacy, safety, and mechanisms of omilancor (BT-11) in patients with moderate to severe Crohn's Disease (CD).

Key Inclusion Criteria:

1. Male and female subjects age 18 to 75 years, inclusive.

2. Diagnosis of CD for at least 6 weeks prior to screening

3. Moderate to severely active CD as defined by all of the following:

   • CDAI score of 220-450
   • PRO-2 stool frequency (SF) ≥ 4 and/or abdominal pain (AP) ≥ 2
   • SES-CD ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader

Key Exclusion Criteria:

1. Participant has ulcerative colitis
2. Participant is at imminent risk of ileo-colectomy
3. Prior enrolment in the current study and had received study treatment.