STATEN ISLAND, N.Y., Aug. 12, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult‑to‑treat bacterial infections, today announced that the Japan Patent Office and the Mexico Patent Office, respectively, have each granted a new patent which covers Acurx's DNA Polymerase IIIC inhibitors including compositions‑of‑matter, methods of use, and pharmaceutical compositions, which further strengthen Acurx's intellectual property portfolio and represents the most recent addition to the Company's expanding series of granted patents in the U.S. and abroad. To date, Acurx has secured six U.S. patents and an additional ten patents internationally, including Australia, Canada, Europe, Israel, India, Japan, Korea, and Mexico , all of which protect key aspects of the Company's ibezapolstat and the ACX‑375C program targeting DNA Polymerase IIIC. Additional country‑level patent applications remain under review.
David P. Luci, President and Chief Executive Officer of Acurx, stated: "Achieving these additional new patents extend our patent estate protection as we further develop ibezapolstat and our innovative, AI-supported drug discovery platform."
Robert J. DeLuccia, Executive Chairman of Acurx, stated, "We believe Acurx's ibezapolstat and preclinical pipeline of systemically absorbed antibiotics has the potential to create a transformational shift in the treatment paradigm of certain serious and potentially life-threatening infections without promoting antibiotic-induced gut dysbiosis. These infections include C. difficile, acute bacterial skin and skin-structure infections (ABSSSI, including MRSA), Community-acquired bacterial pneumonia (CABP), hospital and/or ventilator-associated bacterial pneumonia (HABP/VABP), bacteremia with or without sepsis and/or infectious endocarditis, bone/joint infections, prosthetic joint infections and inhalational anthrax, caused by B. anthracis, a Bioterrorism Category A Threat-Level pathogen."
About Acurx Pharmaceuticals, Inc.Â
Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat 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) may allow NDA filing for both the treatment of acute CDI and the reduction of recurrence of rCDI. Trial start-up activities for the IBZ-PATHFINDER ground-breaking clinical trial in patients with rCDI have been initiated with patient enrollment to begin in the next few months.
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 treatment of inhaled anthrax is being planned in parallel.
Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report on Form 10-K for the year ended December 31, 2025 as filed with the Securities and Exchange Commission on March 12 2026, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward-looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.
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