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Acurx Pharmaceuticals Advances Phase 3

Acurx's ibezapolstat progresses to Phase 3 trials, targeting C. difficile infection and recurrence reduction.

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  • Jan 07, 2025

  • Priyanka Patil

Acurx Pharmaceuticals Advances Phase 3

Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a late-stage biopharmaceutical company focused on developing innovative antibiotics for challenging bacterial infections, announced a significant step forward in its mission to combat C. difficile infection (CDI). The company's lead candidate, ibezapolstat, is set to advance to international Phase 3 clinical trials following positive regulatory feedback from the European Medicines Agency (EMA).

EMA Endorsement and Global Phase 3 Plans

The EMA's recent Scientific Advice Procedure affirmed that Acurx’s clinical, non-clinical, and Chemistry Manufacturing and Controls (CMC) data support the progression of ibezapolstat’s Phase 3 program. Key trial details were validated, including:

  • Trial design: Two non-inferiority studies comparing ibezapolstat to vancomycin.
  • Patient population and endpoints: Clinical Cure as the primary measure, supplemented by secondary endpoints assessing CDI recurrence.
  • Sample size and analysis: Approximately 450 participants, randomized 1:1 in the initial trial, using a Modified Intent-To-Treat (mITT) approach for efficacy analysis.

The trials will evaluate ibezapolstat’s ability to treat CDI and its potential to reduce recurrence, a critical unmet need in this patient population. If non-inferiority is demonstrated, further analysis will explore whether ibezapolstat achieves superiority.

Collaboration with Global Regulatory Agencies

Acurx’s Executive Chairman, Bob DeLuccia, highlighted the collaborative efforts with both the EMA and FDA:
"We are pleased with the latest favorable communications from regulatory agencies, which provide a clear international roadmap for our Phase 3 program and eventual applications for US and EU approvals."

Acurx has already achieved key milestones with the FDA, including agreement on its CMC plan and Phase 3 trial readiness. The company is also preparing to initiate trials in the European Union, with subsequent submissions planned for the UK, Japan, and Canada.

What Makes Ibezapolstat Unique?

Ibezapolstat represents a new class of small molecule antibiotics targeting difficult-to-treat infections like CDI. Unlike standard treatments, it offers potential advantages in efficacy and recurrence prevention. The focus on reducing CDI recurrence, a significant challenge with current therapies, positions ibezapolstat as a potentially game-changing treatment.

Looking Ahead

Acurx’s dual Phase 3 trials mark a pivotal step in addressing the global burden of CDI. With regulatory alignment in place, the company is poised to advance ibezapolstat toward regulatory approval, offering hope to patients battling this challenging infection.

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