Acurx Pharmaceuticals announces positive data from phase 2b trial for C. difficile infection treatment
Acurx Pharmaceuticals has announced that it has discontinued its phase 2b clinical trial of its lead antibiotic candidate, ibezapolstat, for the treatment of patients with Clostridioides difficile infection (CDI) following positive results.
The company has decided to end the trial following consultation with its medical and scientific advisors and statisticians based on data and other information such as the cost of trial sites and slow enrollment due to COVID-19. However, it has announced that the trial performed “as anticipated” for both ibezapolstat and the control antibiotic vancomycin (the current standard of care for patients with CDI). High rates of clinical cure were observed, with no emerging safety concerns.
Robert J DeLuccia, executive chairman of Acurx, commented: “Considering the totality and weight of evidence of our preclinical, phase 1 and phase 2a clinical results and now with the observed aggregate blinded data, we determined it was in the best interests of the company and its shareholders to discontinue the phase 2b clinical trial early and prepare for phase 3 clinical trials. We look forward to compiling, analysing the data and reporting topline results for the study’s primary clinical endpoint and safety aspects as soon as possible. We thank the clinical trial investigators and patients across the country who participated in this study allowing advancement of this promising new antibiotic into late-stage clinical trials for this serious and life-threating infection which is classified by US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) as an urgent priority for which new classes of antibiotics are needed.”
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