Acurx Pharmaceuticals, Inc. (ACXP), a late-stage biopharmaceutical company, announced that it will conduct a new clinical trial with Ibezapolstat in patients with recurrent Clostridioides difficile Infection (rCDI).In parallel, the firm is advancing to Phase 3 international clinical trials to treat patients with C. difficile infection (CDI) with Ibezapolstat, subject to receiving appropriate funding.
Following the news, In the overnight market, ACXP is up 4.35% at $2.04.
Clostridium difficile is an anaerobic, Gram-positive, spore-forming, toxin-secreting bacillus that has long been recognized to be the most common pathogen of antibiotic-associated diarrhea and C. difficile is one of the most common causes of health care-associated infections in U.S. hospitals accounting for 12% of infections.(PubMed Central)
Ibezapolstat is Acurx's lead antibiotic candidate, being developed as a Gram-Positive Selective Spectrum (GPSS) antibacterial planned to treat patients with C. difficile infection (CDI) and now in rCDI.
Notably In 2019, the FDA granted Fast Track designation to Ibezapolstat for the treatment of patients with CDI.
This new clinical trial in rCDI will begin with an open-label pilot trial to gain experience with Ibezapolstat in 20 patients with multiply-recurrent CDI with at least 3 episodes of CDI within the past 12 months.
The trial start-up activities for this new clinical trial in rCDI will be initiated later this month, with the first patient expected to enrol in the fourth quarter this year.
The results from this 20-patient open-label study will help design elements of Phase 3 trial for rCDI which will be an active-controlled, registration trial.If the Phase 3 trial is successful, Acurx plans to apply for approval from the U.S. Food and Drug Administration (FDA) for treatment and prevention of rCDI using a special regulatory pathway called the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).
More details about this new program will be discussed on the company's March 13, 2026 earnings call for full year and fourth quarter 2025 financial results on Friday, March 13, 2026 at 8:00 am ET.
The recently completed Phase 2 clinical trial included a multicenter, open-label single-arm segment (Phase 2a) study followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites.
The Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI, including pharmacokinetics and microbiome changes from baseline.
Notably, in the combined Phase 2 trial, 100% (25 of 25) ibezapolstat-treated patients who had Clinical Cure at End of Treatment(EOT) remained cured through one month after EOT, as compared to 86% (12 of 14) for the vancomycin patient group.
Furthermore, Ibezapolstat-treated patients showed lower concentrations of faecal primary bile acids and a higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.
The Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy.
In the Phase 2b clinical trial in patients with CDI, the exploratory endpoint showed that 5 of 5 Ibezapolstat patients followed for up to three months following Clinical Cure experienced no recurrence of infection.
The company remains confident that, based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96%, Sustained Clinical Cure Rate of 100% and the historical vancomycin Clinical Cure Rate range of 70% to 92% and a Sustained Clinical Cure historical range of 42% to 74%, they will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials.
For the Phase 3 Trial ahead for CDI, the primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population. This will result in an estimated 450 subjects in the mITT population, randomised in a 1:1 ratio to either ibezapolstat or standard- of-care vancomycin, enrolled into the initial Phase 3 trial.
The trial will determine Ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment and will also assess Ibezapolstat's potential effect on the reduction of CDI recurrence in the target population.
If Ibezapolstat demonstrates non-inferiority to vancomycin, further analysis will be conducted to test for superiority.
Robert J. DeLuccia, Executive Chairman of Acurx, stated "Ibezapolstat has been demonstrated in Phase 2 to be highly effective in both curing CDI and in preventing recurrence. We believe ibezapolstat has the potential to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of rCDI, and such success would shift the paradigm of treatment and prevention of rCDI from two agents to one.
Acurx reported a cash balance of $5.9 million for the third quarter ended September 30, 2025.
ACXP has traded between $1.32 and $21 in the past year. The stock closed Monday's trade at $1.95.
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