Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)

NCT05938465 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 28193
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Ileal Pouch

Keywords

Pouchitis; Pouch; Ileal Pouch Anastomosis; IPAA

Outcome Measures

Primary Outcomes (16)

• 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).

  4 weeks

• 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.

  4 weeks

• 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.

  4 weeks

• 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.

  4 weeks

• Phase 1b: Study Treatment Discontinuation Due to Treatment Emergent Adverse Events (TEAEs)

  To assess the safety of EXE-346 using study treatment discontinuation due to TEAE(s).

  4 weeks

• Phase 2: 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 TEAEs and SAEs.

  8 weeks

• Phase 2: 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.

  8 weeks

• Phase 2: 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.

  8 weeks

• Phase 2: 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.

  8 weeks

• Phase 2: Study Treatment Discontinuation Due to Treatment Emergent Adverse Events (TEAEs)

  To assess the safety of EXE-346 using study treatment discontinuation due to TEAE(s).

  8 weeks

• Phase 2: Change in Total Daily Bowel Movement Frequency

  To assess the efficacy of EXE-346 to reduce the total daily bowel movement frequency using change in average daily bowel movement frequency from baseline to each post-baseline week

  8 weeks

• Phase 2 Open Label: 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 TEAEs and SAEs.

  8 weeks

• Phase 2 Open Label: 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.

  8 weeks

• Phase 2 Open Label: 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.

  8 weeks

• Phase 2 Open Label: 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.

  8 weeks

• Phase 2 Open Label: Study Treatment Discontinuation Due to Treatment Emergent Adverse Events (TEAEs)

  To assess the safety of EXE-346 using study treatment discontinuation due to TEAE(s).

  8 weeks

Secondary Outcomes (5)

• Phase 1b: Bowel Movement Frequency

  4 weeks

• Phase 1b: Nighttime Awakening Frequency

  4 weeks

• Phase 1b: Bowel Movement Consistency

  4 weeks

• Phase 2: Nighttime Awakening Frequency

  8 weeks

• Phase 2: Bowel Movement Consistency

  8 weeks

Other Outcomes (14)

• Phase 1b: Change in Fecal Calprotectin Level

  4 weeks

• Phase 2: Change in mPDAI Score

  8 weeks

• Phase 2: Change in Clinical Subscore of mPDAI

  8 weeks

Study Arms (4)

Phase 1b Open Label

EXPERIMENTAL

EXE-346 live biotherapeutic product, 1500x10\^9 colony forming units (CFU) twice daily (BID), 4 weeks

Biological: EXE-346

Phase 2: Active Arm

EXPERIMENTAL

EXE-346 live biotherapeutic product, 1500x10\^9 CFU BID, 8 weeks

Biological: EXE-346

Phase 2: Placebo Arm

PLACEBO COMPARATOR

Powder containing same inactive ingredients as EXE-346 but none of the active ingredients, BID, 8 weeks

Other: Placebo

Phase 2 Open Label Extension (optional)

EXPERIMENTAL

EXE-346 live biotherapeutic product, 1500x10\^9 CFU BID, 8 weeks

Biological: EXE-346

Interventions

EXE-346 BIOLOGICAL

EXE-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.

Phase 1b Open Label; Phase 2 Open Label Extension (optional); Phase 2: Active Arm

Placebo OTHER

Placebo contains excipients maltose and silicon dioxide.

Phase 2: Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly completed at least 7 days of eDiary entries during the screening period (Days -13 to 0).
• Subject is a male or female and is aged 18 years or older at screening.
• Subject is willing and able to provide written informed consent prior to the initiation of any study-related procedures.
• Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly completed at least 7 days of eDiary entries during the screening period (Days -21 to 0).
• Subject has had an IPAA for at least 6 months prior to screening.
• Female subjects of childbearing potential must have a negative serum pregnancy test result at screening and must not be lactating and/or breastfeeding.
• Subjects (female subjects of childbearing potential and male subjects with partners of childbearing potential) must agree to use proper contraceptive methods (see Section 13.2 for contraceptive guidance) to avoid pregnancy during the study. Nonchildbearing potential is defined as at least 6 weeks after a hysterectomy with or without surgical bilateral oophorectomy or postmenopausal (at least 12 months since natural amenorrhea).
• Subjects must have completed the Phase 2 double-blinded part of the study and are willing to participate in the optional open-label extension phase.
• Note: Subjects who discontinued study treatment in the Phase 2 double-blinded part but who have remained in the study for safety monitoring are eligible for continued safety monitoring in the optional open-label extension phase; however, study treatment will not be re-started in such subjects.
• Subjects must understand the study procedures, the risks involved, and are willing to continue to adhere to the study visit/protocol schedule.

You may not qualify if:

• 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.
• Subject has uncontrolled hypertension (systolic pressure \>160 mm Hg or diastolic pressure \>95 mm Hg on at least 2 measures performed at least 10 minutes apart) at screening.
• Subject has Crohn's-like disease of the pouch, as indicated by the pouchoscopy conducted during study screening.
• Subject has isolated severe cuffitis without pouch inflammation (endoscopic mPDAI score of 2 or lower), as indicated by the pouchoscopy conducted during study screening.
• Subject has a clinically significant stricture of the IPAA or afferent limb stricture which requires surgery or recurrent dilations more than every 3 months, as indicated by the pouchoscopy conducted during study screening. Subjects who have a planned dilation during the active study period are excluded (dilation during the screening pouchoscopy is allowed).
• Subject has taken biologics, azathioprine, methotrexate or small molecules (e.g., JAK inhibitors, S1P receptor modulators) within the 12 weeks prior to screening or systemic steroids within 4 weeks prior to screening.
• Subject has a positive reverse transcriptase-PCR diagnostic test for SARS-CoV-2 within the 7 days prior to screening, per subject self report.
• Subject has an average daily bowel movement frequency of \>25 bowel movements recorded during the screening period (Days -21 to 0).
• Subject is taking opioid therapy as a long-term treatment or has taken opioids within 2 weeks prior to screening.
• Subject has taken probiotics within 2 weeks prior to screening.
• Subject has previously received EXE-346 for any duration. Subjects who participated in Phase 1b are excluded from Phase 2.
• Subject has a concurrent, clinically significant, serious, unstable or uncontrolled medical or psychiatric condition that, in the opinion of the investigator, might confound study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.

Sponsors & Collaborators

• Exegi Pharma, LLC: lead
• The Emmes Company, LLC: collaborator

Study Sites (8)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Mayo Clinic - Florida (Inflammatory Bowel Disease Center)

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

NOT YET RECRUITING

Mayo Clinic Department of Gastroenterology

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Penn State Health (Milton S. Hershey Medical Center)

Hershey, Pennsylvania, 17033, United States

RECRUITING

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MeSH Terms

Conditions

Pouchitis

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Study Officials

• Julia Collins, MS

  Exegi Pharma, LLC

  STUDY DIRECTOR

Central Study Contacts

Emmes Project Management

CONTACT

301-251-1161; PROF_Study@emmes.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: July 10, 2023
• Study Start: November 6, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)