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 Clostridium Difficile Infection Recurrence. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Ibezapolstat targets a class of enzymes known as '-stat' enzymes. This mechanism is being studied for its potential to treat Clostridium Difficile Infection and its recurrence.
Ibezapolstat is being developed by Acurx Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACXP.
Ibezapolstat is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. It has received Fast Track, QIDP, RMAT, and Orphan Drug designations.
Ibezapolstat is being studied in two Phase 2 trials. NCT04247542, a completed trial with 53 participants, evaluated oral treatment for Clostridium Difficile Infection. NCT07513285, currently recruiting with a target enrollment of 20, is studying oral treatment for recurrent Clostridium Difficile Infection.
Yes, Ibezapolstat is also known as ACX-362E. Clinical trial records refer to the drug as 'ACX-362E [Ibezapolstat]' in studies for both initial and recurrent Clostridium Difficile Infection.