Acurx Pharmaceuticals Announces Publication in ASM Confirming DNA Pol IIIC Inhibitor Pipeline Data Showing Potential Microbiome-Sparing Class Effect
NASDAQ:ACXP
Overview
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a late-stage biopharmaceutical company developing a new class of antibiotics for serious and life-threatening bacterial infections, announced publication in the ASM (American Society for Microbiology) Microbiology Spectrum journal of results of a study entitled: The effects of novel oral preclinical PolC inhibitor antibiotic candidates on the gut microbiome in a murine thigh infection model. According to the company, the findings confirm in vivo antibacterial activity at tested doses while suggesting that further structural or dosing optimization may enhance tissue-level efficacy.
According to the company, compared with oral linezolid, a commonly used oral therapy for gram-positive infections, orally dosed Pol IIIC inhibitors demonstrated a consistent class characterized by preservation of a Bacteroidota-dominant murine gut community and maintenance of anaerobic metabolic pathways. The company stated that these experiments also highlight the importance of microbiome-informed antibiotic evaluation in preclinical studies.
Key Highlights
- The publication represents, according to the company, the first ever head-to-head comparison of gut microbiome changes associated with novel oral preclinical PolC (pol IIIC*) inhibitors to linezolid in a murine neutropenic thigh infection model.
- Structural molecular modification of molecules related to ibezapolstat (IBZ) improved solubility and systemic exposure of novel Pol IIIC inhibitors, with all three tested Pol IIIC inhibitors reducing MRSA burden in a neutropenic mouse thigh model.
- Pol IIIC inhibitors in the study maintained high gut microbial diversity and preserved microbiome metabolic function, in contrast to the marked disruption shown by linezolid, according to the company.
- Pol IIIC inhibitor compounds specifically preserved anaerobic microbiome components and metabolism, whereas linezolid induced depletion and disruption of healthy anaerobic bacterial communities, the company said.
- Acurx's DNA pol IIIC inhibitor preclinical product candidates are FDA QIDP and Fast-Track eligible and target Gram-positive infections classified as Serious Threat priorities by the CDC, according to the company.
Strategic/Operational Context
Kevin Garey, PharmD, MS, FIDSA, Principal Investigator for microbiology and microbiome aspects of Acurx's DNA pol IIIC program and the Robert L. Boblitt Endowed Professor in Drug Discovery at the University of Houston College of Pharmacy, is the lead author of the study. Garey stated: "Discovering highly selective antibacterial agents that specifically target systemic bacterial pathogens while avoiding the eradication of trillions of health-promoting bacteria in our gut microbiome remains a 'Holy Grail' of antibiotic development. Work in our laboratory with Acurx's novel DNA pol IIIC inhibitors has advanced this work by demonstrating favorable gut microbiome-sparing effects of this novel class of antibiotics. It further emphasizes the value of incorporating microbiome profiling into the earliest phases of new antibiotic clinical research programs."
Robert J. DeLuccia, Executive Chairman of Acurx, stated: "Acurx is at the forefront of pioneering Antimicrobial Stewardship with antibiotics by discovering and developing innovative narrow-spectrum antibiotics which cause minimal gut dysbiosis. This Microbiome Stewardship dimension, which we believe should be fundamental to driving today's drug discovery and development process, is emerging as a new standard in the field of human anti-infective research."
According to the company, its portfolio of preclinical compounds includes clinical applications for infections caused by MRSA such as ABSSI, Hospital Acquired and Ventilator Acquired Bacterial Pneumonia, bacteremia with or without sepsis and/or endocarditis, bone and joint and diabetic foot infections, and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen).
Study Details
According to the company, the purpose of the murine thigh MRSA infection model was to evaluate the in vivo efficacy of the PolC inhibitor compounds using linezolid as a control. Animal experiments were conducted at NeoSome Life Sciences, an American Association for the Accreditation of Laboratory Animal Care-accredited facility, under protocol number NLS24-011. Female CD-1 mice were rendered neutropenic by two intraperitoneal doses of cyclophosphamide and acclimated for 5 days prior to study initiation. All animals were inoculated intramuscularly in the right rear thigh with MRSA strain BAA-1717 (USA 300) at time 0, achieving a final inoculum of 1.8 × 10^5 colony-forming unit (CFU) per mouse thigh. Antibiotic treatment began 1 hour post-infection.
According to the company, the CDC estimates approximately 323,700 hospital cases of MRSA infections annually with approximately 10,600 deaths, and in a recent CDC surveillance study in hospitalized patients in the U.S., MRSA accounted for 52% of all infections, almost twice as many as MDR Gram-negative infections.
What to Watch Next
- The company previously announced that the first patient has been enrolled in its PATHFINDER clinical trial in patients with multiply recurrent C. difficile Infection (rCDI), a fully funded pilot trial in approximately 20 patients intended to support filing of a U.S. NDA based on a single Phase 3 trial, according to the company.
- The planned ASPIRE trial, a non-inferiority design trial expected to include approximately 550 subjects in the mITT population randomized 1:1 to ibezapolstat or standard-of-care vancomycin, will be conducted when the company has sufficient resources from public or private partnership(s) to fund the trial, according to the company.
- Acurx previously announced the outcome of a Type C Meeting conducted with FDA on July 13, 2026, regarding ibezapolstat's Phase 3 clinical program and scope of its planned NDA, with the Agency stating it is open to further discussion at a Pre-NDA Meeting regarding the possibility of submitting an NDA with only a single Phase 3 trial, subject to the totality of the clinical data.
About Acurx Pharmaceuticals, Inc.
Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for serious and life-threatening bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug-resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen).
Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection (CDI) is Phase 3 ready to advance to international clinical trials subject to obtaining appropriate financing. Acurx has received FDA guidance in meeting minutes from a July 13, 2026 Type C Meeting to discuss ibezapolstat's (IBZ) Phase 3 clinical program, including the potential to submit an NDA (New Drug Application) based on a single Phase 3 trial and a clinical trial design intended to support indications for both treatment and reduction of recurrence of Clostridioides difficile infection (CDI). FDA stated that it is open to further discussion on the totality of evidence from the clinical development program at a pre-NDA meeting after completion of a single Phase 3 trial and any other clinical trials conducted prior to the pre-NDA meeting, particularly if the clinical efficacy results are robust. Additionally, the Agency agreed that a successful clinical outcome from a single IBZ-ASPIRE Phase 3 trial, supported by the open-label IBZ-PATHFINDER Phase 2 trial in multiply-recurrent CDI (rCDI) will allow an NDA filing for both the acute treatment and the reduction of recurrence of CDI. The IBZ-PATHFINDER trial is currently enrolling.
The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for prophylaxis of inhaled anthrax is being planned in parallel.
To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com.
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