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

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Recruiting
participants needed

20
sponsor

Acurx Pharmaceuticals LLC

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Updated on 19 February 2024

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Summary

This trial will evaluate the safety, efficacy, pharmacokinetics, fecal concentrations, and fecal microbiome effects of ACX-362E [ibezapolstat] in patients with C. difficile infection (CDI). The current record applies only to Segment 2A, primary completion date August 2020.

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 is an open-label cohort of approximately 20 subjects in approximately 5 study centers in the United States and Canada. In Segment 2A, approximately 20 subjects with diarrhea caused by C. difficile will be treated with ACX-362E 450 mg orally for 10 days. All subjects will be followed for recurrence for 28 2 days. After 10 subjects have completed treatment and again after all subjects have completed treatment, a Trial Oversight Committee will assess the safety and tolerability, and, as data allow, efficacy, to make recommendation regarding whether the study should continue.

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 in Segment 2A. Stool samples will be tested for study drug concentration.

Details

Condition	Clostridium Difficile Infection
Age	18-90 years
Treatment	ACX-362E
Clinical Study Identifier	NCT04247542
Sponsor	Acurx Pharmaceuticals LLC
Last Modified on	19 February 2024

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