ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection

April 2, 2026 updated by: Acurx Pharmaceuticals Inc.

A Phase 2 Interventional, Open-Label, Single-Arm Trial of Oral Ibezapolstat (ACX-362E) for Treatment and Reduction of Recurrent Clostridioides Difficile Infection in Patients With Multiple Recurrent Infections (IBZ-PATHFINDER)

Single-arm trial to evaluate the safety and efficacy of ACX-362E [ibezapolstat] in patients with recurrent C. difficile infection (CDI).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Phase 2 multicenter, open-label, single-arm study is designed to evaluate the efficacy, safety, and tolerability of ibezapolstat in the treatment and reduction of recurrence of CDI in an adult patient population that has experienced ≥3 episodes of CDI within the past 12 months. Up to 20 participants will be treated with ibezapolstat 450 mg taken with food every 12 hours for 14 days (28 total doses) and followed for Clinical Cure (Day 16), Sustained Clinical Cure (Day 42), rate of CDI recurrence (Up to Week 24), and Extended Clinical Cure (ECC) (Up to Week 24).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed diagnosis of CDI as defined by 1) the presence of diarrhea, defined as passage of ≥ 3 UBMs within 24 hours before study Day 1, AND 2) a stool test result positive for the presence of C. difficile free toxins
  • Three or more CDI episodes in the past 12 months, including the current episode, with each episode defined as ≥ 3 unformed stools in 24 hours associated with positive C. difficile toxin test.
  • At least 1 of the protocol-qualifying prior CDI episodes, not including the current episode, has been treated with oral vancomycin or with fidaxomicin

Exclusion Criteria:

  • Severe, complicated, or life-threatening fulminant CDI with evidence of hypotension (systolic blood pressure < 90 mmHg), septic shock, peritoneal signs or ileus, or toxic megacolon
  • Received more than 24 hours of dosing with antibiotics for the current CDI episode:
  • Received a live biotherapeutic product (LBP) (Rebyota® or Vowst™) within the past 12 weeks
  • Received or current use of anti-C. difficile antibodies, eg, IV immunoglobulin [IVIG], bezlotoxumab
  • Active inflammatory bowel disease (Crohn's disease, ulcerative colitis) with chronic diarrhea within 12 weeks before Baseline, or with a history of symptoms > 12 weeks before Baseline without evidence of mucosal healing on colonoscopy within the past year.
  • Active irritable bowel syndrome with chronic diarrhea in the past 12 weeks.
  • Active gastroenteritis because of Salmonella, Shigella, Escherichia coli 0157H7, Yersinia or Campylobacter, other bacteria, a parasite, or a virus within the past 2 weeks
  • Major GI surgery (eg, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).
  • Known current history of a severely compromised immune system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibezapolstat
Active investigational antibacterial agent
Drug: Ibezapolstat
Ibezapolstat 450 mg po Q12H x14 days
Other Names:
  • ACX-362E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the rate of CDI Clinical Cure (CC)
Time Frame: Day 16
Day 16
Evaluate the rate of Sustained Clinical Cure (SCC)
Time Frame: Day 42
Day 42
Evaluate the rate of CDI recurrence (rCDI)
Time Frame: Day 70
Day 70

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the rate of CDI recurrence (rCDI)
Time Frame: Day 42
Day 42
Assess the effects of ibezapolstat on quantitative changes to the fecal microbiome
Time Frame: Day 1 to Week 24
The Shannon Diversity Index and Inverse Simpson Diversity Index will be used to quantify biodiversity in a community like the gut microbiome, measuring how many different species are present in a community (richness) and how close in numbers different species in the community are to each other (evenness).
Day 1 to Week 24
Assess time to resolution of diarrhea during the treatment period
Time Frame: Day 16
Day 16
Assess the incidence of Extended Clinical Cure (ECC)
Time Frame: Weeks 8, 12, and 24
Weeks 8, 12, and 24
Assess the rate of CDI recurrence (rCDI)
Time Frame: Weeks 12 and 24
Weeks 12 and 24

Other Outcome Measures

Outcome Measure
Time Frame
Determine the frequency and severity of adverse events
Time Frame: Day 1 to Week 24
Day 1 to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acurx Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 19, 2026

Primary Completion (Estimated)

September 29, 2027

Study Completion (Estimated)

November 24, 2027

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACX-362E-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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