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Acurx Announces Presentation of a Scientific Poster at the Premier International C. difficile Symposium (ICDS) Demonstrating Superior In Vitro Kill Kinetics of Ibezapolstat vs. Vancomycin and Fidaxomicin (Standards of Care) in Clostridioides difficile and Vancomycin-Resistant Enterococcus Co-Cultures

ACXP
  • Acurx Pharmaceuticals presented a scientific poster at the 9th International C. difficile Symposium in Bled, Slovenia, detailing the in vitro efficacy of ibezapolstat (IBZ) against C. difficile & vancomycin-resistant Enterococcus (VRE).
  • The study found that Enterococcus creates a protective microenvironment that impairs C. difficile killing by standard-of-care antibiotics, reducing efficacy by up to 2.90 logs in co-culture.
  • Ibezapolstat maintained superior bactericidal activity in co-culture conditions, achieving a 5.51-log reduction in C. difficile while significantly outperforming vancomycin.
  • IBZ demonstrated potent activity against both C. difficile & VRE, whereas vancomycin remained inactive against VRE & showed reduced efficacy against C. difficile in the presence of Enterococcus.
  • Transcriptional analysis revealed IBZ was statistically superior to other antibiotics in decreasing VanA cluster abundance & suppressed TcdB gene expression effectively.
  • Acurx holds FDA QIDP & Fast-Track designations, plus EMA SME designation, for ibezapolstat.
  • The company received FDA feedback indicating a single Phase 3 trial might support an NDA submission if data is robust, though a second trial remains recommended if criteria are not met.
  • The planned IBZ-ASPIRE Phase 3 trial is a non-inferiority study involving approximately 550 subjects comparing IBZ to vancomycin for acute treatment & recurrence reduction.
  • Acurx is also launching the IBZ-PATHFINDER trial, an open-label pilot study for multiply recurrent CDI patients with at least three prior episodes in the past 12 months.
  • Ibezapolstat is a novel DNA polymerase IIIC inhibitor with a Gram-positive selective spectrum that spares beneficial gut bacteria & promotes secondary bile acid production to prevent recurrence.