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

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