News & Events zu Acurx Pharmaceuticals Inc (ACXP)ACXPAcurx Pharmaceuticals Inc

Acurx Pharmaceuticals Launches rCDI Clinical Trial PATHFINDER

Acurx Pharmaceuticals announced that the first patient has been enrolled in its new clinical trial, PATHFINDER, in patients with multiply recurrent C. difficile Infection, or rCDI. This is a pilot trial in approximately 20 patients with multiply-recurrent CDI and will support filing of a New Drug Application based on a single Phase 3 trial. The Phase 2 multicenter, open-label, single-arm study evaluates the efficacy and safety of ibezapolstat in the treatment and reduction of recurrence of CDI in patients who have experienced at least 3 episodes of CDI within the past 12 months. Separately, the planned ASPIRE trial is of non-inferiority design with the primary efficacy analysis in the Modified Intent-To-Treat population. The ASPIRE trial will be conducted when the company has sufficient resources from public or private partnership(s) to fund this trial. The FDA acknowledged Acurx's planned clinical trial in rCDI and noted the data from this rCDI trial, if successful, would support an NDA submission. If the IBZ-ASPIRE trial does not meet these criteria, then a second trial consistent with the agreement reached at the end of Phase 2 meeting on April 27, 2024, is recommended. Upon subsequent successful completion of PATHFINDER, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs.

Selling Stockholders Plan to Sell 1.5M Shares of Common Stock

This filing relates to the offer and sale from time to time by the selling stockholders of up to 1.5M shares of common stock. The company is not selling any shares under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders.

Acurx Pharmaceuticals Presents Gut Microbiome Study in New York

Acurx Pharmaceuticals announced a poster presentation presented by Kevin Garey, University of Houston College of Pharmacy, Principal Investigator for microbiology at the 18th Biennial Congress of the Anaerobe Society of the Americas in New York City July 8 to 10. Studies were performed at the University of Houston to determine whether beneficial gut microbes are present in patients with multiple recurrences of Clostridioides difficile infection, or rCDI. The objectives of this study were to determine whether beneficial microbes identified in the IBZ Phase 2 studies in patients with initial and 1st recurrent CDI are still present in patients with multiple recurrent CDI and to assess killing effects of IBZ vs. comparators in planktonic and biofilm mono- and duo-culture studies; specifically, measuring killing of VRE by VAN, FDX, and IBZ in planktonic and biofilm cultures. Data demonstrated beneficial bacterial taxa persist in fecal samples from patients with rCDI despite multiple prior CDI treatments with the antibiotic standards of care, vancomycin and/or fidaxomicin. Following acute treatment with ibezapolstat, these beneficial microorganisms will have the opportunity to repopulate the microbiome in a beneficial way that may prevent recurrence. IBZ and FDX were superior in biofilm experimental models with IBZ significantly more effective at killing C. difficile than VAN and FDX.