Acurx Announces Filing of Provisional Patent Application for Ibezapolstat to Treat CDI While Reducing Recurrence of Infection and Improving the Health of the Gut Microbiome
STATEN ISLAND, N.Y., July 7, 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 it has filed a provisional patent application in the United States Patent and Trademark Office (USPTO). The filing of this patent application relates to ibezapolstat and its use to treat C. difficile Infection while reducing the recurrence of the infection, as well as improving the health of the gut microbiome. This is the latest in the series of patent applications that Acrux has filed to protect its proprietary technologies in the field of antimicrobials. Acurx is commencing a Phase 2b clinical trial in patients with CDI (Clostridioides difficile Infection) during the second half of this year after having recently completed a Ph2a clinical trial which demonstrated that 10 of 10 patients with CDI (100%) met the study's primary and secondary efficacy endpoints of Clinical Cure at end of treatment and Sustained Clinical Cure with no recurrence of CDI at the 28-day follow-up visit.
Acurx continues to pursue protection for its technologies in the United States and internationally. Acurx aims to protect the technology, inventions, know-how, and improvements that are important to the development of its business using the most effective intellectual property instruments.
Robert J. DeLuccia, Executive Chairman of Acurx, stated "We believe that ibezapolstat's Gram-Positive Selective Spectrum (GPSS™), kills C. difficile, but not other Firmicutes necessary for maintaining a healthy microbiome, and it spares the important Actinobacteria phylum needed for maintaining a healthy microbiome." He further stated: "This concept of a dual-effect treatment which includes bactericidal activity against C. difficile bacteria while at the same time providing a restorative effect on the microbiome has the potential to position ibezapolstat as an important first-line therapy for CDI."
David P. Luci, President & CEO of Acurx, stated: "We believe ibezapolstat's dual effect to effectively treat patients with CDI while simultaneously and dramatically reducing the likelihood of recurrence by restoring the microbiome would be a significant therapeutic advance. This dual effect would substantially reduce CDI recurrences and if this trend continues in later-stage clinical trials, and ibezapolstat is ultimately approved, it could have a dramatically positive impact on patient outcomes and on reducing downstream healthcare costs."
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.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the potential of Ibezapolstat, Acurx's future expectations, plans and prospects, including without limitation, Acurx's expectations regarding its growth, strategy, progress and timing of its clinical trials, the potential of its antibiotics, and its intellectual property protection. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the possibility that data from clinical trials will be inconsistent with the data observed in subsequent clinical trials, 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, competition from third parties that are developing products for similar uses, Acurx's ability to obtain, maintain and protect its intellectual property, Acurx's dependence on third parties for development and manufacture of product candidates including to supply any clinical trials, Acurx's ability to manage expenses and to obtain additional funding when needed to support its business activities and establish and maintain strategic business alliances and new business initiatives, and the impacts of public health pandemics such as COVID-19 on business operations including its clinical trials. Additional detailed information concerning a number of the important factors that could cause actual results to differ materially from the forward-looking information contained in this release is readily available in Acurx's publicly filed Registration Statement on Form S-1 and will also be included in quarterly, annual and other reports. Acurx disclaims any obligation to update developments of these risk factors or to announce publicly any revision to any of the forward-looking statements contained in this release, or to make corrections to reflect future events or developments.
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Company Codes: NASDAQ-NMS:ACXP