Acurx Pharmaceuticals Inc (ACXP) has announced efficacy results from its Phase 2 trial of ibezapolstat for the treatment of Clostridioides difficile Infection (CDI). While the combined Phase 2a and 2b trials demonstrated a 96% clinical cure rate, the company's stock price plummeted by over 30% following the announcement.
The Phase 2b trial was initially designed as a non-inferiority trial with vancomycin but was later amended to include an interim efficacy analysis reviewed by an Independent Data Monitoring Committee (IDMC). Factors including cost and enrollment challenges due to the COVID-19 pandemic also influenced the decision to terminate the vancomycin-controlled segment early.
Clinical Trial Results
The overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients). This was based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population. Three patients experienced one mild adverse event each, assessed as drug-related by the blinded investigator. All three events were gastrointestinal in nature and resolved without treatment.
Company Perspective
"Ultimately the marketplace will determine the antibiotic of choice for front-line treatment of CDI," said CEO David Luci. "But, in our view, as we plan to enter Phase 3 pivotal clinical trials, ibezapolstat appears to have the properties for ultimate competitive advantage including high clinical cure rates, low recurrent infection, minimal microbiome disruption and manufacturing efficiencies to allow competitive pricing."
Financial Status
As of June, Acurx Pharmaceuticals had $9.1 million in cash and no debt. The company is proceeding with plans to initiate Phase 3 pivotal clinical trials for ibezapolstat.
