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Wednesday, January 17, 2024

Acurx: 'Positive Partial Comparative Data' for Ibezapolstat from Phase 2b C. diff. Trial

 

  • Ibezapolstat outperformed vancomycin showing eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 treated patients (94%), versus vancomycin which had eradication of C. difficile in 10 of 14 treated patients (71%).
  • Ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent recurrence of CDI
  • Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days
  • Preparation underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials
  • Ibezapolstat has previously received FDA QIDP and Fast-Track Designation

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