Benzinga | Nov 8, 2021 08:07AM EST

Acurx Highlights Nov. 5 Presentation Of New Microbiome Data From Its Phase 2a Clinical Trial Of Ibezapolstat At 9th International C. diff. Conference

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 new microbiome data from its Phase 2a clinical trial for C. difficile Infection (CDI) were presented at the 9th International C. diff Conference & Health Expo entitled: "Can Emerging Microbiome Findings Contribute to CDI Anti-Recurrence Effect?" The presentation was made on November 5, 2021, by Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for microbiome aspects of the ibezapolstat clinical trial program.

Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. Additionally, a decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin.

Dr. Garey's Presentation can be viewed on the company's website at www.acurxpharma.com, Tab: News Media, Presentations.

According to Dr. Garey, "The totality of pre-clinical and clinical data-to-date demonstrate that ibezapolstat fulfills the three key criteria for an ideal anti-CDI antibiotic: Ibezapolstat achieves high colonic concentrations with minimal systemic absorption; it has potent activity against C. difficile while, in contrast to oral vancomycin, causes minimal disruption of the gut microbiome; and it shows a potentially beneficial effect on gut bile acid metabolism. Taken together, these features contribute to the observed clinical success rate and make ibezapolstat, which also shows good tolerability, an attractive potential therapeutic option for CDI."

The Company's upcoming Phase 2b segment of this clinical trial also will evaluate pharmacokinetics (PK) and microbiome changes from baseline and continue to test for anti-recurrence microbiome properties seen in the Phase 2a trial, including the treatment-related changes in alpha diversity and bacterial abundance and effects on bile acid metabolism.

Robert J. DeLuccia, Executive Chairman of Acurx, stated, "We are particularly excited by these results in our Phase 2a CDI patients which are consistent with the favorable microbiome profile when compared with vancomycin in our earlier Phase 1 healthy volunteer trial; particularly this newest information on the beneficial effect on bile acids." He further stated that "We look forward to beginning enrollment in our Phase 2b trial this month, which will compare ibezapolstat to vancomycin, the standard of care in CDI."