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.
Parallel
EXE-346
Biological/VaccineEXE-346 contains a proprietary, fixed-dose, lyophilized blend of 8 strains of gram positive, lactic acid bacteria. EXE-346 excipients are maltose and silicon dioxide.
Placebo
Other interventionPlacebo contains excipients maltose and silicon dioxide.
Phase 1b: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
To assess the safety of EXE-346 using incidence, severity, relationship to study treatment, and frequency of treatment emergent adverse events (TEAE) and serious adverse events (SAE).
Phase 1b: Number of Participants with Abnormal Physical Examinations
To assess the safety of EXE-346 using abnormal findings in physical examinations after the start of study treatment that suggest a clinically significant worsening of medical issue.
Phase 1b: Number of Participants with Abnormal Vital Signs
To assess the safety of EXE-346 using abnormal findings in vital sign readings after the start of study treatment that suggest a clinically significant worsening of medical issue, including blood pressure.
Phase 1b: Number of Participants with Abnormal Safety Labs
To assess the safety of EXE-346 using markedly abnormal findings in safety labs after the start of study treatment that suggest a clinically significant worsening of medical issue.
Phase 1b: Bowel Movement Frequency
To assess the effect of EXE-346 on bowel movement frequency using change in average daily bowel movement frequency from baseline to each post-baseline week
Phase 1b: Nighttime Awakening Frequency
To assess the effect of EXE-346 on nighttime awakening frequency using change in average nighttime awakenings for bowel movements from baseline to each post-baseline week
Phase 1b: Bowel Movement Consistency
To assess the effect of EXE-346 on bowel movement consistency using change in average consistency of daily bowel movements from baseline to each post-baseline week
Phase 2: Nighttime Awakening Frequency
To assess the effect of EXE 346 on nighttime awakening frequency using change in average nighttime awakenings for bowel movements from baseline to each post-baseline week
Phase 1b: Change in Fecal Calprotectin Level
To evaluate the effect of EXE-346 on fecal calprotectin levels after 4 weeks. The change from baseline fecal calprotectin level will be evaluated at Day 15 and Day 29.
Phase 2: Change in mPDAI Score
To evaluate the effect of EXE-346 on the mPDAI total score from baseline to day 57.
Phase 2: Change in Clinical Subscore of mPDAI
To evaluate the effect of EXE-346 on the mPDAI clinical subscores after 8 weeks. Change from baseline clinical subscores will be calculated at Day 15, Day 29, and Day 57.
Phase 2: Change in Endoscopic Subscore of mPDAI
To evaluate the effect of EXE-346 on the mPDAI endoscopic subscore from baseline to day 57.
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Exegi Pharma, LLC
Lead sponsor
The Emmes Company, LLC
Collaborator
