Acurx Pharmaceuticals recently 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 3 episodes over the past 12 months), and will support filing of a US New Drug Application (NDA) based on a single phase 3 trial.

The PATHFINDER phase 2 multicenter, open-label, single-arm study evaluates the efficacy and safety of ibezapolstat (IBZ) 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. Participants will be treated with IBZ for 14 days and assessed for Clinical Cure (day 16), Sustained Clinical Cure (day 42), rate of CDI recurrence (to week 24), and Extended Clinical Cure (to week 24).

Separately, the planned ASPIRE trial is of non-inferiority design with the primary efficacy analysis in the Modified Intent-To-Treat (mITT) population and will result in approximately 550 subjects in the mITT population, randomised in a 1:1 ratio to either IBZ or Standard-of-Care (SoC) vancomycin. The ASPIRE trial will be conducted when the company has sufficient resources from public or private partnership(s) to fund this trial.

Bob DeLuccia, Executive Chairman, Acurx, stated, "We're very excited about our current momentum in moving ibezapolstat a few steps closer toward commercialisation having a clearly defined regulatory and clinical pathway. 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 2 agents to 1. This would be a game changer to the public health threat that affects approximately 500,000 patients with CDI each year in the US, resulting in approximately 30,000 deaths, and generating a related public health cost burden of approximately USD 5 billion, of which USD 2.8 billion is related to rCDI."

Acurx previously announced the successful outcome of a Type C Meeting conducted with FDA on July 13, 2026 to discuss IBZ's phase 3 clinical program and scope of its planned NDA. The agency stated that it is open to further discussion at a pre-NDA meeting regarding the possibility of submitting an NDA with only a single phase 3 trial, depending on the totality of the clinical data plus any other supportive data that Acurx may generate by that milestone.

The agency noted that determination of acceptability of one phase 3 clinical trial for an NDA is made on a case-by-case basis, taking into consideration such factors as the magnitude, consistency, and overall robustness of the efficacy results; generalisability of the results to the US population; relevance of the results to US patient care and clinical practice guidelines; phase 2 data; and an adequate safety database.

The agency acknowledged Acurx's planned clinical trial in recurrent CDI (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 (EOP2) meeting on April 27, 2024, is recommended.

The currently planned IBZ-ASPIRE trial is of non-inferiority design with the primary efficacy analysis in the Modified Intent-To-Treat (mITT) population. This will result in approximately 550 subjects in the mITT population, randomised in a 1:1 ratio to either IBZ or SoC vancomycin. The agency also agreed with the overall trial design and evaluation criteria and further agreed that the trial testing criteria, if successful, could support indications for both the acute treatment and the reduction of recurrence of CDI.

In the event, non-inferiority of ibezapolstat to vancomycin for Clinical Cure of CDI is demonstrated, further analyses will be conducted to test for superiority for reduction of recurrence and for clinical cure of CDI.