Acurx Pharmaceuticals Inc. (NASDAQ: ACXP) has announced the publication of positive results of its Phase 2a clinical study in Clinical Infectious Disease, the official Infectious Disease Society of America publication. Dr Kevin Garey, chair and professor at, University of Houston College of Pharmacy and the lead investigator for the microbiome aspects of the study, was the publication’s senior author.
Ibezapolstat has properties ideal for CDI antibiotic
Garey stated, “In this publication, we are particularly pleased to present the totality of the ibezapolstat Phase 2a clinical and microbiome data for this promising novel antibiotic which appears to possess key properties of an ideal oral antibiotic for CDI: highly potent against C. difficile; good tolerability; and limited gastrointestinal absorption, resulting in very high faecal concentrations which may reach three orders of magnitude above the MIC for C. difficile.”
He added that the first-in-class Gram-Positive Selective Spectrum (GPSS) antimicrobial is a proprietary DNA polymerase IIC inhibitor with a distinctive action mechanism targeting gram-positive bacteria with low G+C concentration. Ibezapolstat has significant action, as evidenced by C. difficile elimination on the third-day f treatment. The findings also demonstrate that it surprisingly spares additional Firmicutes and the important Actinobacteria phylum, both of which are required for a functional microbiome. When contrasted to standard care vancomycin, such properties, together with ibezapolstat’s capacity to favorably enhance the proportion of secondary-to-primary bile salts in the colon, imply that ibezapolstat may lower the chance of CDI recurrence.
Enrolment in Phase 2b ongoing
Acurx executive Chairman Robert DeLuccia, stated, “Considering the entirety of our preclinical, Phase 1 and Phase 2a clinical results and the favorable microbiome signature of ibezapolstat compared to vancomycin, we are confident of a high probability of successful Phase 2b trial outcome. In the event ibezapolstat demonstrates non-inferiority to vancomycin, further analysis will be conducted to test for superiority.”
Currently, the company is enrolling subjects in the phase 2b segment, which is an important clinical development milestone for Acurx. The company expects to complete trial enrolment by mid-2022 despite the challenges posed by the pandemic and emerging variants.
