Acurx presents Phase 2 results of ibezapolstat in C. difficile Infection

Acurx Pharmaceuticals announced that results from the ibezapolstat Phase 2 clinical trial in patients with C. difficile Infection, or CDI, were presented at the 17th Biennial Congress of the Anaerobe Society of the Americas on July 11th at the University of Michigan. Acurx previously had a successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for ibezapolstat for the Treatment of C. difficile Infection. Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of CDI. Acurx is also now preparing to submit requests for guidance to initiate clinical trials in the EU, the UK, Japan and Canada. Additional analyses of clinical and microbiological data from the Phase 2b segment show favorable gut microbiome changes including increased relative proportion of Actinobacteria in ibezapolstat-treated patients with CDI. Results were consistent with those shown in earlier human volunteer studies and Phase 2a studies. Preservation and increased concentrations of beneficial Firmicute phylum known to be involved in bile acid homeostasis and short chain fatty acid metabolism was demonstrated. Actinobacteria and Bacteroides preservation were also confirmed using quantitative analysis. In January 2019, FDA granted “Fast Track” designation to ibezapolstat for the treatment of patients with CDI.