Acurx Pharmaceuticals Profile
Acurx Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, engages in developing a class of antibiotics for infections caused by bacteria listed as priority pathogens by the World Health Organization (WHO), the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).
The company's approach is to develop a new class of antibiotic candidates that block the DNA polymerase IIIC enzyme (Pol IIIC). Its research and development pipeline includes clinical stage and early-stage antibiotic candidates that target Gram-positive bacteria for oral and/or parenteral treatment of infections caused by Clostridium difficile (C. difficile), Enterococcus (including vancomycin-resistant strains (VRE)), Staphylococcus (including methicillin-resistant strains (MRSA)), and Streptococcus (including antibiotic resistant strains).
Pol IIIC is required for the replication of DNA in certain Gram-positive bacterial species. By blocking this enzyme, the company's antibiotic candidates focus to be bactericidal and inhibit proliferation of several common Gram-positive bacterial pathogens, including both sensitive and resistant C. difficile, MRSA, vancomycin-resistant Enterococcus, penicillin-resistant Streptococcus pneumonia PRSP) and other resistant bacteria.
The company intends to 'de-risk' this new class of antibiotics through its drug development activities and potentially partner with a fully-integrated pharmaceutical company for late-stage clinical trials and commercialization.
The company's lead antibiotic candidate, ibezapolstat, has a novel mechanism of action that targets the Pol IIIC enzyme, a previously unexploited scientific target. Phase 2a clinical data validate the efficacy of its lead antibiotic candidate, as well as Pol IIIC as an appropriate bacterial target. On December 3, 2021, the company commenced enrollment in a Phase 2b 64-patient, randomized (1-to1), non-inferiority, double-blind trial of oral ibezapolstat compared to oral vancomycin, a standard of care to treat C. difficile infections (CDI).
Prior to that, the company completed its Phase 2a clinical trial of ibezapolstat to treat patients with CDI and reported the top-line data in November 2020. The Phase 2a clinical trial was terminated early based upon the recommendation of its Scientific Advisory Board (the SAB). The SAB unanimously supported the early termination of the Phase 2a trial after 10 patients were enrolled in the trial instead of 20 patients as originally planned. The early termination was further based on the evidence of meeting the treatment goals of eliminating the infection with an acceptable adverse event profile.
The company's Phase 2b clinical trial commenced enrollment on December 3, 2021.
The company also has an early-stage pipeline of antibiotic product candidates with the same previously unexploited mechanism of action which has established proof of concept in animal studies. This pipeline includes ACX-375C, a potential oral and parenteral treatment targeting Gram-positive bacteria, including MRSA, VRE, and PRSP.
Based upon advice from the company's scientific advisors, it focuses ACX-375C, its second antibiotic candidate in pre-clinical development, will also be eligible for FDA's qualified infectious disease product (QIDP) and fast track designations. This advice is supported by the 'qualifying' criteria for a QIDP listed in GAIN Act legislation of 2012 enacted as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).
The company has worked closely with the FDA to obtain its investigational new drug application (IND), and to obtain FDA fast track designation, as well as designation of ibezapolstat as a qualified infectious disease product (QIDP), which provides incentives through the Generating Antibiotic Incentives Now Act (the GAIN Act), including FDA priority review for the first application submitted for the QIDP, fast track designation eligibility and extension of statutory exclusivity periods in the U.S. for an additional 5 years upon FDA marketing approval of the product to treat patients with CDI.
Intellectual Property
The company has two U.S. patents (U.S. Patent Numbers 6,926,763 and 8,796,292), with claims that cover ibezapolstat that expire in May 2023 and September 2030, respectively. The most important U.S. patent in management's view, is the composition-of-matter patent (8,796,292), which expires in September 2030. Patent Number 6,926,763 includes claims that cover disubstituted purine compounds, compositions, surface coatings, and methods of treating bacterial infection or inhibiting bacterial growth, and these claims cover ibezapolstat. Patent Number 8,796,292 includes other claims that cover other disubstituted purine compounds, compositions, and methods of inhibiting bacterial growth and these claims cover ibezapolstat. Either patent may be subject to extension subject to certain circumstances.
For ibezapolstat, it also has one composition-of-matter patent in each of Europe, Japan, and Canada. All of these non-U.S. patents expire in September 2030, subject to extension under certain circumstances.
In addition, the company has filed three provisional patent applications in 2021 covering methods of treating C. difficile infection and preventing recurrence, as well as simultaneous promotion of microbiome health. It filed a non-provisional patent application and an international patent application in 2022 covering methods of treating C. difficile infection and preventing recurrence while simultaneously promoting microbiome health. It also filed a new provisional patent application in 2022 covering compositions and methods to promote gut microbiome health.
The FDA has granted QIDP status for the oral use of ibezapolstat to treat CDI. QIDP status is provided by the FDA under the GAIN Act and provides incentives for the company as the sponsor of the ibezapolstat development program, including FDA priority review for the first application submitted for the QIDP, eligibility for 'fast track' status and extension of statutory exclusivity periods in the U.S. for an additional five years upon FDA approval of ibezapolstat for the treatment of CDI. In January 2019, the FDA approved 'fast track' designation for ibezapolstat for the oral treatment of CDI. Accordingly, the company will have 10 years of regulatory exclusivity on the oral use of ibezapolstat to treat CDI from the date of FDA marketing approval.
The company has obtained three U.S. patents and one Israeli patent on ACX-375C, its second antibiotic program, and has a fourth U.S. patent application and multiple foreign applications pending for ACX-375C. The company's three U.S. patents and Israeli patent on ACX-375C include composition-of-matter, surface coating, and method of use claims. Absent any patent extensions, these patents will expire in December 2039.
Research and Development
The company's research and development expenses were $4.8 million for the year ended December 31, 2022.
Regulation
The company works with the FDA to obtain its investigational new drug application (IND), and to obtain FDA fast track designation, as well as the designation of ibezapolstat as a QIDP, which provides incentives through the GAIN Act, including FDA priority review for the first application submitted for the QIDP, fast-track designation eligibility and extension of statutory exclusivity periods in the U.S. for an additional five years upon FDA approval of the product for the treatment of CDI.
History
Acurx Pharmaceuticals, Inc., a Delaware corporation, was founded in 2017. The company was incorporated in 2017.
