Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (“Acurx” or the “Company”), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that the FDA has accepted the Company’s plan to have an Independent Data Monitoring Committee (IDMC) conduct an interim review of clinical outcome from the ongoing Ph2b clinical trial of patients with C. difficile Infection (CDI).
STATEN ISLAND, N.Y., April 11, 2023 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (“Acurx” or the “Company”), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that the FDA has accepted the Company’s plan to have an Independent Data Monitoring Committee (IDMC) conduct an interim review of clinical outcome from the ongoing Ph2b clinical trial of patients with C. difficile Infection (CDI). The interim review will be conducted upon reaching enrollment of 36 patients in total. FDA’s acceptance was based on the Company’s filing of a protocol amendment to its Investigational New Drug Application (IND) with FDA in January 2023. The Company’s filing and intention for the IDMC to conduct an interim review of data was based on the observed blinded data to date from the ongoing Ph2b clinical trial at that time. Upon conducting the interim review, the IDMC will determine and recommend to the Company whether the most appropriate course of action is to terminate the Ph2b clinical trial early due to success, as the Company had done with the Ph2a clinical trial, or to continue patient enrollment. The Company intends to report available data promptly after the IDMC conducts this interim review. The IDMC initial organizational meeting was conducted in March 2023 and it has completed all organizational matters required to ensure readiness for data review. Additionally, spokespersons for the Company will be presenting at the 33rd Annual European Congress of Clinical Microbiology and Infectious Disease (ECCMID) this month. Specifically, a scientific poster entitled “Novel pharmacology and susceptibility of ibezapolstat against C. difficile isolates with reduced susceptibility to C. difficile-directed antibiotics” will be presented by Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for microbiome aspects of our ibezapolstat clinical trial program. Poster Presentation: Also, Acurx Executive Chairman, Robert J. DeLuccia, will present an update on the Company’s preclinical, systemic oral and IV program for treatment of other gram-positive infections caused by MRSA, VRE and DRSP at the “Pipeline Corner” featured session at ECCMID, organized by Dr. Ursula Theuretzbacher, a world-renowned microbiology expert for antibacterial drug research, discovery and development strategies and policies for clinical and public health needs. Pipeline Corner Presentation: About Ibezapolstat The Company currently is enrolling patients in a Ph2b clinical trial of ibezapolstat to treat patients with C. difficile infection (CDI). The Company successfully completed Phase 1 and Phase 2a clinical trials of ibezapolstat. The Phase 2a trial demonstrated 100% clinical cure and 100% sustained clinical cure in patients with CDI, along with beneficial microbiome changes during treatment including overgrowth of Actinobacteria and Firmicutes phylum species while on therapy and new findings which demonstrate potentially beneficial effects on bile acid metabolism. The Ph2b clinical trial is designed to enroll 64 patients and is a randomized (1:1), non-inferiority, double-blind trial of oral ibezapolstat compared to oral vancomycin, a standard of care to treat CDI. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted “Fast Track” designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. About ECCMID About Clostridioides difficile Infection (CDI). According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate of two of the three antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%. About the Microbiome in Clostridioides difficile Infection (CDI) and Bile Acid Metabolism Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company’s Ph2a trial results and previously reported. (CID, 2022) About the Ibezapolstat Phase 2 Clinical Trial About Acurx Pharmaceuticals, Inc. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com. Forward-Looking Statements 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 filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2022, 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. Investor Contact: SOURCE Acurx Pharmaceuticals, Inc. | ||
Company Codes: NASDAQ-NMS:ACXP |
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