Acurx Pharma To Conduct New Clinical Trial In Patients With rCDI While Its Program In Broader CDI Patient Population Is Ready To Advance To Phase 3 International Clinical Trials

Acurx's Program in the Broader CDI Patient Population is Ready to Advance to

Phase 3 International Clinical Trials

• Acurx is launching a ground-breaking clinical trial with ibezapolstat in patients with multiply-recurrent CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one
• When coupled with IBZ Phase 2 results of being highly effective (96% clinical cure of 26 patients) in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this new trial will position IBZ as a candidate to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of rCDI
• In a Phase 2 trial, all 25 patients treated with IBZ who experienced a clinical cure of CDI were free of recurrence 1 month after treatment and 5 of 5 (100%) of these patients who were observed for 3 months after treatment remained free of recurrence
• Recent unpublished data from Dr. Kevin Garey's laboratory at the University of Houston demonstrate that 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, indicating that, following acute treatment with IBZ, these beneficial microorganisms will have the opportunity to repopulate the microbiome in a favorable way that may prevent recurrence
• Trial start-up activities for this new clinical trial in rCDI will initiate later this month with the first patient expected to enroll in the fourth quarter this year. This open-label trial will enroll up to 20 patients whose CDI has recurred at least twice following standard of care antibiotic treatment within the past 12 months.
• Acurx has previously been granted FDA QIDP and Fast-Track Designation and has received SME (Small and Medium-sized Enterprise) designation by the EMA

STATEN ISLAND, N.Y., March 9, 2026 /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 it will conduct a new clinical trial in patients with recurrent C. difficile Infection (rCDI) while its program in the broader CDI patient population is ready to advance to Phase 3 international clinical trials, subject to receiving appropriate funding. This new clinical trial in rCDI begins with an open-label pilot trial to gain experience with IBZ in patients with multiply-recurrent CDI with at least 3 episodes of CDI within the past 12 months. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs (Guidance for Industry, 2020).