Acurx Pharma to Present Ibezapolstat Phase 2 Results at ESCMID 2024

Acurx Pharmaceuticals, Inc., a biopharmaceutical company focused on creating new antibiotics for challenging bacterial infections, has announced promising results from its Phase 2 clinical trial of ibezapolstat in treating Clostridioides difficile Infection (CDI). The findings were presented at the 34th Congress of ESCMID Global, held in Barcelona, Spain, from April 27-30, 2024.

Kevin Garey, Professor and Chair of the University of Houston College of Pharmacy and Principal Investigator for the ibezapolstat clinical trial program, delivered an oral presentation titled "A Phase 2, Randomized, Double-Blind Study of Ibezapolstat Compared with Vancomycin for the Treatment of Clostridioides difficile Infection." This presentation detailed the clinical and microbiological data from the Phase 2b segment of the trial.

In addition to Dr. Garey's presentation, Dr. Eugenie Basseres from the University of Houston College of Pharmacy showcased a poster highlighting the antibacterial effectiveness of ibezapolstat against antimicrobial-resistant C. difficile strains. Dr. Garey emphasized the significance of these results, noting that ibezapolstat’s ability to inhibit DNA polymerase IIIC translates into effective activity against strains with reduced susceptibility to existing treatments like fidaxomicin and vancomycin. He also mentioned that this new antibiotic could offer a valuable option as resistant strains continue to emerge.

Dr. Garey's presentation underscored that the randomized study demonstrated ibezapolstat's effectiveness was comparable to vancomycin in achieving clinical cures for mild-to-moderate CDI. Importantly, none of the patients treated with ibezapolstat experienced a recurrence of CDI within the 28-day follow-up period, suggesting strong anti-recurrence properties. This supports further development into Phase 3 trials, with more extensive microbiome studies planned to confirm these findings.

The Phase 2 clinical trial included a Phase 2a segment, which was an open-label study involving 20 patients treated with ibezapolstat. All participants showed a clinical cure at the end of the treatment period. The Phase 2b segment was a double-blind, randomized controlled trial involving 32 patients, who received either ibezapolstat or vancomycin. Both treatments showed high rates of clinical cure, with ibezapolstat demonstrating a 96% cure rate across both phases of the trial.

The trial revealed ibezapolstat to be well-tolerated, with only mild gastrointestinal adverse events reported, all of which resolved without additional treatment. There were no serious adverse events or treatment withdrawals due to the drug. Based on these positive results, Acurx aims to demonstrate ibezapolstat’s non-inferiority to vancomycin in future Phase 3 trials, adhering to FDA guidance.

The Phase 2 clinical trial also evaluated pharmacokinetics and microbiome changes, revealing that ibezapolstat significantly increased the concentration of beneficial secondary bile acids while reducing primary bile acids. This suggests a lower likelihood of CDI recurrence compared to vancomycin.

Ibezapolstat, designated by the FDA as a Qualified Infectious Disease Product (QIDP) and granted "Fast Track" status, is set to advance to international Phase 3 trials. This novel antibiotic, through its unique mechanism, maintains a healthy gut microbiome by targeting Gram-positive bacteria without affecting other important microbial populations.

Overall, these findings highlight the potential of ibezapolstat as a significant advancement in the treatment of CDI, addressing both initial infection and recurrence, which remains a significant medical challenge.