Acurx Pharmaceuticals has announced positive results from its Phase IIb clinical trial comparing ibezapolstat to vancomycin in the treatment of Clostridioides difficile infection (CDI).
Ibezapolstat, the company's lead antibiotic candidate, showed a 94% eradication rate of fecal C. difficile at day three of treatment, surpassing the 71% rate observed with vancomycin.
Additionally, the therapy preserved beneficial gut bacteria, potentially reducing CDI recurrence. Further analyses are expected in the first quarter of 2024, with plans to progress to international Phase III clinical trials.
The Phase IIb trial, conducted across 28 sites in the US, was designed to evaluate ibezapolstat's efficacy, including its impact on the microbiome and pharmacokinetics.
The trial followed a successful Phase IIa segment, where ibezapolstat achieved a 100% cure rate at the end of treatment in a small cohort.
The decision to conclude the Phase IIb trial early was based on the high clinical cure rates and absence of safety concerns.
Ibezapolstat has already received the US Food and Drug Administration (FDA) Qualified Infectious Disease Product and fast-track designation.
Acurx executive chairman Robert DeLuccia said: “These new comparative data are very important and timely to enhance our data package for an end of Phase II FDA Meeting, which is targeted for the second quarter this year.
“Parallel preparations continue on schedule for Phase III clinical trials start-up later this year, including timely availability of clinical trial supply.”
The company is preparing for discussions with the FDA, the European Medicines Agency and other global regulatory bodies.
Acurx president and CEO David Luci said: “Ibezapolstat continues to demonstrate success compared to a standard of care, oral vancomycin, to treat patients with CDI. We anticipate that favourable differentiation between the two therapeutic options will continue to be shown in Q1 [first quarter] 2024, including extended clinical cure and additional microbiome comparison data.”
