Acurx Pharmaceuticals Stock Is Plummeting After Biotech Publishes Phase 2 Results

Acurx Pharmaceuticals Inc ACXP shares are trading lower after the company released efficacy results from a Phase 2 trial.

The company, which had $9.1 million in cash and no debt in June, previously decided to terminate the Phase 2b vancomycin-controlled trial segment early. Aggregate blinded data showed a high observed clinical cure rate with no emerging safety concerns. 

Acurx also decided that the clinical cure rate for ibezapolstat, to treat C. difficile Infection (CDI), was projected to be at least 90% pooled across the open-label Phase 2a and the blinded Phase 2b segments with no safety concerns noted. 

Other factors, including the cost and the challenging enrollment due to the COVID-19 pandemic, also influenced the decision.

The Phase 2b trial was originally designed to be a non-inferiority (NI) trial and was later amended to include an interim efficacy analysis with review by an Independent Data Monitoring Committee (IDMC). 

The overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), 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 each experienced one mild adverse event assessed by the blinded investigator to be drug-related. 

All three events were gastrointestinal in nature and resolved without treatment. 

"Ultimately the marketplace will determine the antibiotic of choice for front-line treatment of CDI," CEO David Luci said. "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."

Price Action: ACXP shares are down more than 31% at $3.48 on the last check Thursday.