Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ibezapolstat · 2 trials · 2 indications
Percentage of patients with CC at the test of cure (TOC) visit on day 12. CC was defined as survival and the resolution of diarrhea in the 24-hour period immediately before end of treatment (EOT--day 10) that was maintained for 48 hours post EOT without a requirement for additional CDI treatment. Diarrhea was defined as 3 or more unformed bowel movements (UBMs) in a 24-hour period; fewer than 3 UBMs was considered as resolution of diarrhea. A UBM was defined as a Type 5, 6, or 7 bowel movement on the Bristol Stool Chart.
Percentage of patients with CC at the test of cure (TOC) visit on day 12. CC was defined as survival and the resolution of diarrhea in the 24-hour period immediately before end of treatment (EOT--day 10) that was maintained for 48 hours post EOT without a requirement for additional CDI treatment. Diarrhea was defined as 3 or more unformed bowel movements (UBMs) in a 24-hour period; fewer than 3 UBMs was considered as resolution of diarrhea. A UBM was defined as a Type 5, 6, or 7 bowel movement on the Bristol Stool Chart.
Percentage of patients with CC at the test of cure (TOC) visit on day 12. CC was defined as survival and the resolution of diarrhea in the 24-hour period immediately before end of treatment (EOT--day 10) that was maintained for 48 hours post EOT without a requirement for additional CDI treatment. Diarrhea was defined as 3 or more unformed bowel movements (UBMs) in a 24-hour period; fewer than 3 UBMs was considered as resolution of diarrhea. A UBM was defined as a Type 5, 6, or 7 bowel movement on the Bristol Stool Chart.
| Arm | Type | Description |
|---|---|---|
| Ibezapolstat | EXPERIMENTAL | Active investigational antibacterial agent |
| Vancomycin | ACTIVE_COMPARATOR | Standard of care: Vancomycin 125 mg po Q6H x 10 days |
| Name | Type | Description |
|---|---|---|
| Ibezapolstat | DRUG | Ibezapolstat 450 mg po Q12H x14 days |
| Vancomycin | DRUG | Active comparator |
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, includi...
Ibezapolstat is an investigational small molecule being developed for the treatment of Clostridium difficile infection and the prevention of Clostridium difficile infection recurrence. It is currently in Phase 2 clinical development for both indications.
Ibezapolstat is a small molecule that belongs to the -stat class of enzyme inhibitors. It targets a bacterial enzyme, though the specific enzyme is not disclosed in the available information. Its mechanism is being studied for treating Clostridium difficile infection.
Ibezapolstat is being developed by Acurx Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ACXP. The company is conducting clinical trials to evaluate the drug for Clostridium difficile infection and its recurrence.
Ibezapolstat is in Phase 2 clinical development. It has received Fast Track designation and Qualified Infectious Disease Product (QIDP) designation from the FDA. The drug is investigational and has not been approved by regulatory authorities.
Ibezapolstat has one completed Phase 2 trial, NCT04247542, which enrolled 53 participants with Clostridium difficile infection in the United States. A second Phase 2 trial, NCT07513285, is planned for recurrent Clostridium difficile infection with an estimated enrollment of 20 participants.
Yes, Ibezapolstat is also known as ACX-362E. Clinical trial records refer to the drug as ACX-362E [Ibezapolstat], confirming that both names refer to the same investigational compound.