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