Acurx Pharmaceuticals Announces First Patient Enrolled in PATHFINDER Clinical Trial of Ibezapolstat in Multiply-Recurrent C. difficile Infection
Key Highlights
- ➤First patient enrolled in PATHFINDER Phase 2 trial for multiply-recurrent CDI (ACXP)
- ➤PATHFINDER will evaluate ibezapolstat in approximately 20 multiply-recurrent CDI patients
- ➤Successful PATHFINDER could support a U.S. NDA based on one Phase 3 trial
- ➤ASPIRE Phase 3 trial plans approximately 550 patients, subject to funding availability
- ➤FDA agreed successful ASPIRE and PATHFINDER results could support acute and recurrence-reduction indications
Expert Statements
Bob DeLuccia, Executive Chairman of Acurx Pharmaceuticals
“We're very excited about our current momentum in moving ibezapolstat a few steps closer toward commercialization having a clearly defined regulatory and clinical pathway.”
Bob DeLuccia, Executive Chairman of Acurx Pharmaceuticals
“We believe ibezapolstat has the potential to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of rCDI, potentially shifting the paradigm of treatment and prevention of rCDI from two agents to one.”
Acurx Pharmaceuticals Announces First Patient Enrolled in PATHFINDER Clinical Trial of Ibezapolstat in Multiply-Recurrent C. difficile Infection PR Newswire
* PATHFINDER is a ground-breaking Phase 2 clinical trial with ibezapolstat (IBZ) in patients with multiply-recurrent CDI (C. difficile Infection) (rCDI) that, together with results from the planned ASPIRE Phase 3 trial in the broader patient population for the treatment of acute CDI, has potential to shift the paradigm of treatment and prevention of rCDI from two agents to one * PATHFINDER by itself in patients with multiply-recurrent CDI will inform elements of a planned active-controlled, Phase 3 registration trial in rCDI. 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* * Acurx is well positioned to commence its international pivotal Phase 3 ASPIRE trial, subject to funding availability, having both FDA and EMA alignment on the Phase 3 clinical program and pathway to U.S. NDA and MAA in the EU * 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., Sept. 29, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that the first patient has been enrolled in its new clinical trial (PATHFINDER) in patients with multiply recurrent C. difficile Infection (rCDI). This new, fully funded,PATHFINDER clinical trial is a pilot trial in approximately 20 patients with multiply-recurrent CDI (at least three episodes over the past 12 months), and will support filing of a U.S. NDA (New Drug Application) based on a single Phase 3 trial.
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