Clinical Development Program
Acurx has completed its Phase 2b clinical trial of ibezapolstat compared to vancomycin, a standard of care to treat C. difficile infection or CDI. The Phase 2b clinical trial was a randomized (1-to-1), non-inferiority, double-blind trial (n=32) of oral ibezapolstat compared to oral vancomycin, a standard of care to treat CDI. Data will be analyzed and topline efficacy results will be reported as soon as possible in Q4 2023.
The Company successfully completed Phase 1 and Phase 2a clinical trials of ibezapolstat. The Phase 2a trial demonstrated 100% clinical cure at end of treatment and 100% sustained clinical cure in patients with C. difficile Infection (CDI), along with beneficial microbiome changes during treatment including overgrowth of Actinobacteria and Firmicutes phylum species while on therapy and new findings which demonstrate potentially beneficial effects on bile acid metabolism.
The Phase 1 clinical trial included a head-to-head comparison of oral ibezapolstat to oral vancomycin for impact on the microbiome and the results were exceptional, leading to the creation of a new exploratory endpoint in the Phase 2b clinical trial to continue to compare the impact on the microbiome between ibezapolstat and standard of care oral vancomycin.
We intend to meet with the FDA after analyzing the Phase 2b clinical trial data to finalize the size and scope of the Phase 3 clinical trial program. Regulatory precedent indicates that two Phase 3 trials of approximately 275-325 patients each may need to be conducted.
Additional information about the trial can be found in our press release, dated October 2, 2023, and at www.clinicaltrials.gov (Study identifier: NCT04247542).
In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.