Acurx Pharmaceuticals‘ Ibezapolstat Advances too Phase 3 Trials After Securing Japanese Patent

STATEN ISLAND, N.Y., feb. 19, 2025 — Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) announced a notable milestone in its fight against antibiotic-resistant infections.The Japanese Patent Office (JPO) granted a new patent in January 2025, covering DNA Polymerase IIIC Inhibitors, including compositions, surface coatings, and pharmaceutical compositions for treating Gram-positive bacterial infections. This expands Acurx’s intellectual property portfolio, which already includes three U.S.patents, one Israeli patent, and now one japanese patent, all related to the ACX-375C program.

This patent strengthens Acurx’s market position and enhances the value of its pipeline. The company is actively pursuing additional patent applications globally to protect its proprietary technologies. This aggressive approach underscores Acurx’s commitment to innovation in the antimicrobial field.

Complementing our global patent estate with minimally absorbed oral ibezapolstat,now Phase 3-ready for the treatment and prevention of recurrence of C. difficile Infection, this patent, with others to follow, is very vital and timely as we further develop our innovative, AI-supported drug discovery platform of second-generation DNA pol IIIC inhibitors, said Robert J. DeLuccia, Executive Chairman of Acurx. He added, Other compounds in our program are systemically absorbed for potential oral and parenteral use in multiple clinical settings for treatment of infections caused by other gram-positive bacteria, such as Staphylococcus aureus, including MRSA and B. anthracis or anthrax; a Bioterrorism Category A threat-Level pathogen.

Acurx’s progress extends beyond patent acquisition. The company received positive regulatory guidance from the European Medicines Agency (EMA) during its Scientific Advice Procedure. The EMA confirmed that the submitted clinical, non-clinical, and CMC (Chemistry, Manufacturing, and Controls) facts package supports advancement of the ibezapolstat Phase 3 program and, if triumphant, supports a marketing authorization request (MAA) for regulatory approval in Europe. This package detailed Acurx’s planned Phase 3 international, 1:1 randomized clinical trials (designed as non-inferiority trials vs vancomycin), including primary and secondary endpoints, sample size, statistical analysis plan, and the overall registration safety database. With consistent feedback from both the EMA and the U.S. Food and Drug Administration (FDA), Acurx is poised to begin its international Phase 3 registration program.

Phase 2 Clinical Trial Results

Acurx’s completed Phase 2 clinical trial, comprising a Phase 2a and a Phase 2b segment at 28 U.S. clinical trial sites, evaluated ibezapolstat’s efficacy in treating CDI, including pharmacokinetics and microbiome changes. the Phase 2a segment treated 10 patients with C. difficile-induced diarrhea with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28 ± 2 days.All 10 patients (100%) achieved a clinical cure at the end of treatment.

The Phase 2b segment, discontinued early due to success, enrolled 32 patients randomized 1:1 to ibezapolstat or vancomycin for 10 days, followed for 28 ± 2 days for recurrence. The overall observed clinical Cure rate in the combined Phase 2 trials was 96% (25 out of 26 patients): 100% in Phase 2a (mITT population) and 94% in Phase 2b (Per Protocol Population). Ibezapolstat was well-tolerated, with three patients experiencing mild, drug-related gastrointestinal adverse events that resolved without treatment. There were no drug-related treatment withdrawals or serious adverse events. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure.

The company also evaluated pharmacokinetics (PK) and microbiome changes, including alpha diversity and bacterial abundance, particularly the overgrowth of actinobacteria and Firmicute phyla. Phase 2a data showed complete eradication of colonic C. difficile by day three and overgrowth of healthy gut microbiota. Emerging data indicate increased secondary bile acids during and after ibezapolstat therapy, known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and a favorable increase in the secondary-to-primary bile acid ratio suggest ibezapolstat may reduce CDI recurrence compared to vancomycin. Positive extended clinical cure (ECC) data showed that 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure experienced no recurrence.

About Ibezapolstat and CDI

Ibezapolstat,Acurx’s lead antibiotic candidate,is a novel,orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. Its the first of a new class of DNA polymerase IIIC inhibitors.Its unique spectrum of activity, sparing Firmicutes and Actinobacteria, appears to maintain a healthy gut microbiome. In June 2018, ibezapolstat received Qualified Infectious Disease Product (QIDP) designation from the FDA for treating CDI, and in 2019, received Fast Track designation. the Centers for Disease Control and Prevention (CDC) has designated C. difficile as an urgent threat.

According to the 2017 IDSA/SHEA Clinical Practice Guidelines (published February 2018), CDI remains a significant problem. C. difficile is a common cause of healthcare-associated infections in U.S. hospitals. Estimates suggest nearly 500,000 infections and approximately 20,000 deaths annually in the U.S. (Lessa, et al, 2015, New England Journal of Medicine; Guh, 2020, New England Journal of Medicine). Acurx estimates the annual incidence approaches 600,000 infections with a mortality rate of approximately 9.3%. The recurrence rate for current antibiotics is 20% to 40% among approximately 150,000 treated patients.

C. difficile can be a normal gut component, but imbalance allows it to thrive and cause infection. After colonization, it produces toxins A (TcdA) and B (TcdB), responsible for inflammation and intestinal damage (Kachrimanidou, Microorganisms 2020, 8, 200). Bile acids maintain a healthy microbiome by inhibiting C. difficile growth.Primary bile acids promote spore germination, increasing recurrence risk, while secondary bile acids, produced by gut microbiota, protect against recurrence. Ibezapolstat’s minimal microbiome disruption allows continued secondary bile acid production,potentially contributing to its anti-recurrence effect. This was observed in the Phase 2a trial and further supported in the Phase 2b trial, were ibezapolstat-treated patients showed lower fecal primary bile acids and a higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Acurx Pharmaceuticals,Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company developing small molecule antibiotics for difficult-to-treat bacterial infections. Its approach involves Gram-positive selective spectrum (GPSS®) antibiotic candidates that block DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and causing Gram-positive bacterial cell death. Its R&D pipeline includes candidates targeting gram-positive bacteria, including Clostridioides difficile, MRSA, VRE, DRSP, and B. anthracis. Ibezapolstat,for CDI,is Phase 3 ready,with plans to begin international clinical trials. the preclinical pipeline includes an oral candidate for ABSSSI (Acute Bacterial Skin and Skin Structure Infections), with a parallel inhaled anthrax treatment program planned.