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

  • STATUS
    Recruiting
  • days left to enroll
    66
  • participants needed
    74
  • sponsor
    Acurx Pharmaceuticals Inc.
Updated on 4 October 2022
diarrhea
aspart
stool test

Summary

Segments 2A and 2B of this trial evaluate the safety, efficacy, pharmacokinetics, fecal concentrations, and fecal microbiome effects of ACX-362E [ibezapolstat] in patients with C. difficile infection (CDI).

Description

This Phase 2, multicenter, open-label single-arm segment (2A) followed by a double-blind, randomized, active-controlled segment (2B) is designed to evaluate ACX-362E in the treatment of CDI. Segment 2A of this trial was an open-label study of up to 20 patients at 6 study centers and was terminated early at 10 patients based on the protocol-specified Trial Oversight Committee's assessment of the compelling efficacy and safety data. Patients were treated with 450 mg of oral ibezapolstat bid for 10 days. In segment 2A all (10 of 10) patients were cured of CDI at end of treatment and all (10 of 10) were sustained clinical cures 30 days after EOT. Ibezapolstat was well tolerated with no reported SAEs. The trial will advance to Segment 2B which is a double-blind comparison of ibezapolstat to the standard of care, oral vancomycin, in approximately 64 subjects (1-1 randomization) at up to approximately 15 sites.

Subjects will be evaluated for cure, safety, and tolerability. All subjects in both segments will have stool samples tested for microbiome profiles. Pharmacokinetic (PK) testing for systemic exposure will be performed on blood samples. Stool samples will be tested for study drug concentration.

Details
Condition Clostridium Difficile Infection
Treatment Vancomycin, ACX-362E, Ibezapolstat
Clinical Study IdentifierNCT04247542
SponsorAcurx Pharmaceuticals Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female 18 to 90 years of age, inclusive, at the time of Screening
Capable of reading, understanding, and signing the written informed consent; able to adhere to all study procedures and attend all scheduled study visits
Confirmed diagnosis of mild or moderate CDI as defined by the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines (McDonald et al. 2018). Subjects will be diagnosed with CDI based on clinical and laboratory
findings
The presence of diarrhea, defined as passage of ≥ 3 UBMs within 24 hours before dosing; an unformed stool is defined as a Type 5, 6, or 7 on the Bristol Stool Chart (Appendix 2)
A stool test result positive for the presence of C. difficile free toxins using tests that detect toxin A/B (and it is prospectively agreed with the Sponsor). The Sponsor will provide a toxin A/B test kit if the site does not have it as part of standard of care test
Mild or moderate CDI as defined as a white blood cell count of ≤ 15000 cells/mL and a serum creatinine level < 1.5 mg/dL

Exclusion Criteria

Received more than 24 hours of dosing (> 4 doses) of oral vancomycin for the current episode of CDI before first dose of study drug
Received more than 24 hours of dosing (> 2 doses) of oral fidaxomicin for the current episode of CDI before first dose of study drug
Received more than 24 hours of dosing (> 3 doses) of oral/IV metronidazole for the current episode of CDI before first dose of study drug
Received any other antibacterial therapy for the current CDI episode within 48 hours before the first dose of study drug
Subjects considered treatment failures on prior antibiotics for their current episode of CDI will be excluded
More than 3 episodes of CDI in the previous 12 months or more than 1 prior episode in the last 3 months, excluding the current episode
Severe, complicated, or life-threatening fulminant CDI with evidence of hypotension (systolic blood pressure less than 90 mmHg), septic shock, peritoneal signs or ileus, or toxic megacolon
Elevated liver transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) greater than 2 times ULN
Active inflammatory bowel disease (Crohn's disease, ulcerative colitis, Irritable Bowel Syndrome with chronic diarrhea)
Any other non-C. difficile diarrhea
Active gastroenteritis because of Salmonella, Shigella, Escherichia coli 0157H7, Yersinia or Campylobacter, a parasite, or virus within the past 2 weeks
Had a known positive diagnostic test for other relevant gastrointestinal [GI] pathogens in the 2 weeks before study drug treatment and/or colonization/infection by ova or parasites
Major GI surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy)
Prior or current use of anti-C. difficile toxin antibodies
Have received a vaccine against C. difficile or its toxins
Anticipated that systemic antibacterial therapy for a non-CDI infection will be required for > 7 days after start of study therapy
Actively taking anti-diarrheals, and unable to discontinue anti-diarrheal medication, or any medication with the potential to slow bowel movement (for opiates, a stable dose, including use as needed, is permitted)
Actively taking Saccharomyces boulardii and unwilling to discontinue during the study period
Received a fecal transplant in the previous 3 months
Received laxatives in the last 48 hours
Unable or unwilling to stop taking oral probiotics for the duration of the study
Received intravenous immunoglobulin within 3 months before study drug treatment
Sepsis
Have a known current history of significantly compromised immune system such as
Subjects with a known history of human immunodeficiency virus infection and CD4 <200 cells/mm3 within 6 months of start of study therapy
Severe neutropenia with neutrophil count < 500 cells/mL
Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy
Pregnant or lactating women
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