Ibezapolstat Phase 2 Results Presented at ESCMID Global 2024

Acurx Pharmaceuticals, a biopharmaceutical firm focused on developing antibiotics for hard-to-treat bacterial infections, has reported positive results from the Phase 2 clinical trial of their lead drug candidate, ibezapolstat, used for treating C. difficile Infection (CDI). The outcomes were unveiled at the ESCMID Global conference in Barcelona, a significant international event that draws over 14,000 professionals in the field of clinical microbiology and infectious diseases.

The Phase 2 study was a multicenter trial conducted across 28 sites in the U.S., consisting of an open-label single-arm segment (Phase 2a) followed by a double-blind, randomized, active-controlled, non-inferiority segment (Phase 2b). The trial aimed to assess the efficacy of ibezapolstat in treating CDI, its impact on pharmacokinetics, and changes in the microbiome from the baseline. It also sought to examine the anti-recurrence microbiome properties, including alterations in alpha diversity and bacterial abundance, and the effects on bile acid metabolism.

During Phase 2a, an open-label cohort of 10 patients received ibezapolstat 450 mg orally, twice daily for 10 days, with all patients showing a 100% cure rate at the end of the treatment. The Phase 2b segment involved 32 patients with CDI who were randomized to receive either ibezapolstat or vancomycin, both for 10 days. The treatments were matched in appearance and dosing to preserve the blind. The combined Phase 2 trials reported a 96% clinical cure rate in patients with CDI treated with ibezapolstat, with the drug being well-tolerated and showing no serious adverse events related to the treatment.

Ibezapolstat works by inhibiting DNA polymerase IIIC, which is crucial for its activity against C. difficile strains that have reduced susceptibility to other antibiotics like fidaxomicin and vancomycin. Notably, none of the patients treated with ibezapolstat experienced a recurrence of CDI within a 28-day follow-up period, highlighting its potential as a valuable therapeutic option, especially as antimicrobial resistance continues to rise.

The Phase 2b trial was discontinued early due to the success observed, a decision made in consultation with medical and scientific advisors. The trial's early termination was based on blinded clinical observations, which indicated that both ibezapolstat and vancomycin performed as anticipated, with high cure rates.

Ibezapolstat has been recognized by the FDA as a Qualified Infectious Disease Product (QIDP) and has been granted "Fast Track" designation for the treatment of CDI. The CDC has identified C. difficile as an urgent threat, underscoring the urgency for new treatment options like ibezapolstat.

ESCMID Global is a leading forum that offers various sessions, including keynotes, symposia, and workshops, and is governed by an elected Executive Committee with its administrative office based in Basel, Switzerland.

Acurx Pharmaceuticals is dedicated to developing a new class of small molecule antibiotics targeting Gram-positive bacteria, including C. difficile, MRSA, VRE, and DRSP. The company's approach focuses on creating antibiotic candidates with a Gram-positive selective spectrum that inhibits the DNA replication of these bacteria.