What is the mechanism of action of this treatment?

The most common treatments for Clostridium Difficile Infection (CDI) include fidaxomicin, vancomycin, and metronidazole. Fidaxomicin inhibits bacterial RNA polymerase, leading to the cessation of protein synthesis and bacterial death. Vancomycin disrupts cell wall synthesis by binding to peptidoglycan precursors, causing cell lysis. Metronidazole, although less effective, works by generating free radicals that damage bacterial DNA. These mechanisms are crucial for CDI patients as they target the bacteria responsible for the infection, reducing symptoms and preventing recurrence. ACX-362E (ibezapolstat) is being studied for its ability to inhibit DNA polymerase IIIC, essential for bacterial DNA replication in Gram-positive bacteria, offering a novel approach that could potentially enhance treatment efficacy and reduce resistance.

What side effects are associated with this type of intervention?

The most common treatments for Clostridium Difficile Infection (CDI) include oral fidaxomicin, oral vancomycin, and metronidazole. Fidaxomicin is generally well-tolerated but can cause nausea, vomiting, and abdominal pain. Oral vancomycin may lead to nausea, abdominal pain, and potential nephrotoxicity. Metronidazole, while less effective, can cause nausea, a metallic taste, and peripheral neuropathy, and should be avoided in older or frail patients. These treatments differ from ACX-362E (ibezapolstat), which inhibits DNA polymerase IIIC, essential for bacterial DNA replication in Gram-positive bacteria, and may have a different side effect profile.

What prior FDA approvals exist?

The FDA has approved several treatments for Clostridium difficile infection (CDI). Notably, fidaxomicin, a narrow-spectrum antibiotic, has been approved and is known for its minimal impact on the gut microbiome. Vancomycin, another FDA-approved treatment, is a broad-spectrum antibiotic often used for severe cases of CDI. Metronidazole was previously a common treatment but has seen higher rates of treatment failure. Bezlotoxumab, a monoclonal antibody, has also been approved to reduce recurrence of CDI. These treatments, while effective, differ in their mechanisms from ACX-362E (ibezapolstat), which specifically targets DNA polymerase IIIC, essential for bacterial DNA replication in Gram-positive bacteria.

What other types of research exist?

Promising novel alternatives to ACX-362E for Clostridium Difficile Infection in 2024 include fidaxomicin, a narrow-spectrum antibiotic that inhibits RNA polymerase, and bezlotoxumab, a monoclonal antibody that neutralizes C. difficile toxin B. Additionally, fecal microbiota transplantation (FMT) is gaining traction as an effective treatment for recurrent CDI by restoring healthy gut flora.

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DNA synthesis inhibitor

Ibezapolstat for Clostridioides Difficile Infection

Phase 2

Waitlist Available

Research Sponsored by Acurx Pharmaceuticals LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 38 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ibezapolstat for treating C. difficile infections. It focuses on patients who need better treatment options. The drug works by killing the harmful bacteria in the gut and has shown promising results in early tests.

Who is the study for?

Adults aged 18-90 with mild or moderate Clostridioides difficile infection (CDI), experiencing diarrhea as defined by the Bristol Stool Chart. Participants must have a confirmed diagnosis of CDI, not be on certain treatments like immunoglobulins, fecal transplants, or specific antibiotics for CDI before the study. They should not have inflammatory bowel disease, other non-C. difficile diarrhea causes, severely compromised immune systems, recent major GI surgery, or require long-term non-CDI antibiotics.

What is being tested?

The trial is testing ACX-362E [ibezapolstat] against vancomycin to see which is safer and more effective for treating CDI. It will also look at how ibezapolstat affects the body (pharmacokinetics), its concentration in feces and its impact on gut bacteria (fecal microbiome).

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical antibiotic-related issues such as stomach upset, allergic reactions, changes in liver enzymes indicative of liver stress or damage and alterations to normal gut flora leading to symptoms like bloating or discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 38 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~38 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 38 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical cure

Percentage of patients with adverse events

Secondary study objectives

Percentage of patients with sustained clinical cure

Plasma and fecal concentrations of ACX-362E

Other study objectives

Change in EQ-5D-5L Quality of Life scores

Microbiome effects

Time from outset of treatment to the first formed bowel movement

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IbezapolstatExperimental Treatment1 Intervention

Active investigational antibacterial agent: ibezapolstat 450 mg po Q12H x 10 days

Group II: VancomycinActive Control1 Intervention

Standard of care: Vancomycin 125 mg po Q6H x 10 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibezapolstat

2020

Completed Phase 2

~40

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Clostridium Difficile Infection (CDI) include fidaxomicin, vancomycin, and metronidazole. Fidaxomicin inhibits bacterial RNA polymerase, leading to the cessation of protein synthesis and bacterial death. Vancomycin disrupts cell wall synthesis by binding to peptidoglycan precursors, causing cell lysis. Metronidazole, although less effective, works by generating free radicals that damage bacterial DNA. These mechanisms are crucial for CDI patients as they target the bacteria responsible for the infection, reducing symptoms and preventing recurrence. ACX-362E (ibezapolstat) is being studied for its ability to inhibit DNA polymerase IIIC, essential for bacterial DNA replication in Gram-positive bacteria, offering a novel approach that could potentially enhance treatment efficacy and reduce resistance.