Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (“Acurx” or the “Company”), announced today that a scientific abstract and poster were presented on September 29th at the Infectious Disease Society of America (IDSA) IDWeek™ 2021 Virtual Conference entitled: “An Open-label Phase 2a study of Ibezapolstat, a Unique Gram-positive Selective Spectrum (GPSS™) Antibiotic, for Patients with Clostridioides difficile Infection.”
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STATEN ISLAND, N.Y., Oct. 4, 2021 /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, announced today that a scientific abstract and poster were presented on September 29th at the Infectious Disease Society of America (IDSA) IDWeek™ 2021 Virtual Conference entitled: "An Open-label Phase 2a study of Ibezapolstat, a Unique Gram-positive Selective Spectrum (GPSS™) Antibiotic, for Patients with Clostridioides difficile Infection." These results were presented by Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for microbiome aspects of the clinical trial program for ibezapolstat. The Company's upcoming Phase 2b segment of this clinical trial will also evaluate pharmacokinetics (PK) and microbiome changes from baseline and continue to test for anti-recurrence microbiome properties seen in the Phase 1 trial, including the treatment-related changes in alpha diversity and bacterial abundance. The Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment as well as the observed overgrowth of healthy gut microbiota Actinobacteria and Firmicute phyla species during and after therapy. According to Dr. Garey, "The good tolerability, promising efficacy outcomes, minimal systemic exposure, and differential microbiome effects relative to vancomycin all support the continued clinical development of ibezapolstat. He added: "Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. Furthermore, ibezapolstat demonstrated decreased proteobacteria overgrowth in contrast to vancomycin." Robert J. DeLuccia, Executive Chairman of Acurx, stated, "We are particularly excited by these results in CDI patients which are consistent with the favorable microbiome profile when compared with vancomycin in our earlier Phase 1 healthy volunteer trial. He further stated that "We look forward to beginning enrollment in our Phase 2b trial which will compare ibezapolstat to the standard of care, vancomycin, and is expected to begin enrollment this quarter." Dr. Garey's E-Poster Scientific Exhibit can be viewed on the company's website www.acurxpharma.com, Tab: News Media, Presentations. 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) About the Ibezapolstat Phase 2 Clinical Trial. About Acurx Pharmaceuticals, Inc. 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 United States Food and Drug Administration or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other factors. In addition, the forward-looking statements included in this press release represent our views as of October 4, 2021. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward- looking statements at some point in the future, we specifically disclaim any obligation to do so. Investor Contact:
SOURCE Acurx Pharmaceuticals, Inc. |
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Company Codes: NASDAQ-NMS:ACXP |
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