Acurx Announces Publication in Lancet Microbe of Phase 2b Clinical Trial Data for Ibezapolstat in CDI
As previously reported, 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population experienced Clinical Cure (CC) and all 15 of 15 (100%) remained free of C. difficile infection (CDI) recurrence through one month after EOT
In contrast, 2 of 14 (14%) patients treated with the standard of care, oral vancomycin, experienced recurrent infection within one month after EOT
When Phase 2b results are combined with Phase 2a results, 25 of 25 (100%) ibezapolstat-treated patients with CDI who had CC at EOT remained recurrence-free through 1 month after EOT; additionally, all 5 Phase 2b ibezapolstat-treated patients observed for up to 3 months following CC experienced no recurrence of infection
Adding to this Lancet Microbe publication, two recent Journal of Antimicrobial Agents and Chemotherapeutics publications regarding, respectively, favorable gut microbiome effects which differentiate IBZ from other anti-CDI antibiotics and positive results from an in-silico study predicting the microbiome-restorative potential of IBZ
The totality of ibezapolstat data-to-date further advances Acurx's robust data package and are reshaping the therapeutic landscape for future treatment of CDI with ibezapolstat's innovative and potentially transformative new class of antibiotics to treat gram-positive infections while preserving and restoring the protective gut microbiota
Acurx is well positioned to begin international Phase 3 clinical trials and has previously been granted FDA QIDP and Fast-Track Designation and has received SME (Small and Medium-sized Enterprise) designation by the EMA
STATEN ISLAND, N.Y., June 17, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. Its lead antibiotic candidate, ibezapolstat (IBZ), is ready to advance to international Phase 3 clinical trials for treatment of patients with C. difficile infection (CDI). The Company today announced the publication of results in Lancet Microbe of its Phase 2b clinical study entitled: Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat compared with vancomycin in adults with Clostridioides difficile infection: a phase 2b, randomized, double-blind, active-controlled, multicenter study. The senior author is Kevin Garey, PharmD, MS, FIDSA, Professor and Chair, University of Houston College of Pharmacy, and Principal Investigator for microbiology and microbiome aspects of the IBZ clinical trial program, and a co-author of the IDSA (Infectious Diseases Society of America) C. difficile Treatment Guidelines.
Professor Garey noted that current US and European treatment guidelines for CDI recommend only two antibiotics for treatment of CDI: oral vancomycin (VAN) or fidaxomicin (FDX). VAN is most commonly used with a low CC rate of 70-92% and an SCC rate of 42-71%. FDX has fewer recurrences but low rates of CC (84%) and SCC (67%); furthermore, both FDX and VAN are associated with emerging antimicrobial resistance. Dr. Garey also stated: "The clinical need for a new antibiotic, like IBZ, to treat CDI is underscored by a study recently published in Clinical Infectious Diseases conducted in a hospital setting, documenting that C. difficile isolates with clinically relevant reduced fidaxomicin susceptibility may emerge during therapy and spread to other patients. The medical community should be aware of this alarming finding."
Acurx's Executive Chairman, Bob DeLuccia, stated: "This Lancet Microbe article complements the body of our published data to date, the totality of which establishes a comprehensive and formidable dossier to support our optimism for a successful Phase 3 clinical program and, if successful, first choice of IBZ as a front-line treatment for CDI. Our publications include data on IBZ chemistry, mechanism of action, microbiological activity, in vivo efficacy in the hamster model, human efficacy and safety, and favorable effects on the gut microbiome and bile acid metabolism." He further stated: "Data from our Phase 3 pivotal trials, if successful, will form the foundation for our continually evolving and attractive value proposition including in-market competitive advantage compared to vancomycin and fidaxomicin. Additionally, continuing optimization of our 'home-grown and made-in-America" supply chain will ensure scalability and reliability to be accessible and affordable worldwide".
This most recent publication adds important scientific information to supplement a growing list of peer-reviewed publications, including a Phase 1 study showing IBZ to be well-tolerated, localized to the gastrointestinal tract, and associated with preservation and restoration of beneficial gut microbiota. These Phase 2b study findings were supported by a Phase 2a, open-label, non-comparative study and showed 10 of 10 subjects were cured of CDI with no recurrence of infection. Based on this evidence, the Phase 2b study was initiated to assess the efficacy, safety, and associated microbiome changes of IBZ versus standard of care vancomycin (VAN).
This Phase 2b multi-site study was conducted at US medical clinics and hospitals. In the publication, Professor Garey summarized results which included high rates of CC in IBZ-treated subjects treated with no recurrence; furthermore, IBZ was found to be safe, well-tolerated, and associated with the preservation and restoration of key health-promoting bacteria responsible for bile acid homeostasis, a key component in preventing recurrent CDI. The publication establishes that IBZ shows potential as a novel antibiotic treatment for CDI with high rates of CC and SCC while minimally disturbing the protective gut microbiota, thus further supporting its clinical development.
THE ABOVE-MENTIONED PUBLICATIONS ARE ON OUR WEBSITE: www.acurxpharma.com
Lancet Microbe: Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat compared with vancomycin in adults with Clostridioides difficile infection: a phase 2b, randomized, double-blind, active-controlled, multicenter study
Clinical Infectious Diseases: Emergence and Spread of Clostridioides difficile Isolates with Reduced Fidaxomicin Susceptibility in an Acute Care Hospital
About the Lancet Microbe
The Lancet Microbe is the world-leading microbiology research journal and publishes clinically relevant content on microbes at all scales, from the nature of the microbe (eg, antimicrobial resistance genes/plasmids, virulence factors) to the microbiome, to pathology (including immunology) to population level effects (eg, outbreaks, epidemiology). It also publishes early phase clinical trials and other interventional studies where the outcomes are focused on the pathogen. It is an internationally trusted source of clinical, public health, and global health knowledge.
About Clinical Infectious Diseases
Clinical Infectious Diseases (CID) is a leading journal in the field of infectious disease with a broad international readership. The Journal publishes articles on a variety of subjects of interest to practitioners and researchers. Topics range from clinical descriptions of infections, public health, microbiology, and immunology to the prevention of infection, the evaluation of current and novel treatments, and the promotion of optimal practices for diagnosis and treatment. The Journal publishes original research (as Major Articles or Brief Reports), Review Articles, Viewpoints, Editorials, Invited Commentaries, Photo Quizzes, Practice Guidelines, Correspondence, and Supplements and is among the most highly cited journals in the field of infectious diseases. Clinical Infectious Diseases is an official publication of the Infectious Diseases Society of America.
Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if t
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