Acurx Pharmaceuticals, Inc., a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, has announced that a new patent has been granted by the Japanese Patent Office (JPO) in January 2025. 

This patent relates to DNA Polymerase IIIC Inhibitors, including compositions-of-matter, surface coatings and pharmaceutical compositions for use in methods of treating Gram-positive bacterial infection.

This is the latest in the series of granted patents and pending patent applications that Acrux has filed to protect its proprietary technologies in the field of antimicrobials. To date, Acurx has obtained three US patents, one Israeli patent and now one Japanese patent, in each case, which cover the ACX-375C program, relating to DNA Polymerase IIIC Inhibitors, with other country-level filings in process.

Robert J. DeLuccia, Executive Chairman of Acurx, stated, “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 important and timely as we further develop our innovative, AI-supported drug discovery platform of second-generation DNA pol IIIC inhibitors.”

He further added, “Other compounds in our program are systemically absorbed for potential oral and parenteral use in multiple clinical settings for the 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 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 the advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a marketing authorization application (MAA) for regulatory approval in Europe. 

The information package submitted to EMA by the company to which agreement has been reached with EMA included details on Acurx's two planned Phase 3 international, 1:1 randomised clinical trials (designed as non-inferiority trials vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well-positioned to commence our international Phase 3 registration program.

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 design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event that non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.