A Phase 1b/2 Study to Demonstrate the Safety and Efficacy of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an Ileal Pouch-Anal Anastomosis

Brief description of study

The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic product (LBP)containing a fixed proportion mixture of 8 individual bacterial strains, which may reduce bowel movement frequency in patients with an IPAA and lead to a higher quality of life (QoL). The Phase 1b part of the study is an open label (OL), single-arm study to assess the safety of EXE-346 administered orally at a dose of 1500 × 109 CFU BID for up to 4 weeks. The Phase 2 part of the study will initially be a randomized, double-blinded study to assess the safety and efficacy of the same dose of EXE-346 administered orally BID for up to 8 weeks, compared with placebo. Subjects who complete this Phase 2 double-blinded part of the study will be eligible to participate in an optional OL extension phase. Subjects who participate in the optional OL extension phase will receive EXE-346 orally at a dose of 1500 × 109 CFU BID for up to 8 weeks.


Clinical Study Identifier: s23-01258
ClinicalTrials.gov Identifier: NCT05938465
Principal Investigator: Shannon Chang.
Other Investigators: Simon J Hong, Adam Faye, Ariela Holmer, David P Hudesman, Jordan E Axelrad.


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