The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic, which may reduce bowel movement frequency in patients with an ileal pouch-anal anastomosis (IPAA) and lead to a higher quality of life.
Phase 1b Only
Subject is a male or female and is between the age of 18 to 70 years, inclusive, at screening.
Subject has had a documented pouchoscopy within 12 months prior to screening.
Subject or the subject's legally authorized representative is willing and able to provide written informed consent prior to the initiation of any study-related procedures.
Subject has Crohn's-like disease of the pouch, as indicated by their most recent pouchoscopy during the 12 months prior to screening.
Subject has a stricture of the IPAA or afferent limb stricture, as indicated by their most recent pouchoscopy during the 12 months prior to screening.
Subject has taken biologics, azathioprine, or methotrexate within the 12 weeks prior to screening or systemic steroids within 4 weeks of screening.
Subject has a positive reverse transcriptase-PCR diagnostic test for SARS-CoV-2 within the 14 days prior to screening.
Exegi Pharma, LLC
Lead sponsor
The Emmes Company, LLC
Collaborator