Advancement to Phase 3 Trials
Acurx is finalizing preparation to advance ibezapolstat into international Phase 3 clinical trials for treating C. difficile infection, with the potential for regulatory approval in both the US and EU.
Positive Phase 2b Clinical Results
Ibezapolstat demonstrated a 100% clinical cure rate in the Phase 2 program, with no infection recurrence in patients followed for three months post-treatment.
Regulatory Support from FDA and EMA
Received positive regulatory guidance from both the FDA and EMA, aligning on the Phase 3 program's clinical, non-clinical, and manufacturing aspects.
New Patent in Japan
Granted a new patent for DNA polymerase IIIC inhibitors, supporting ongoing development of ACX-375C, with potential applications against MRSA, VRE, and Anthrax.
Financial Improvements
Net loss decreased to $2.8 million in Q4 2024 from $5.1 million in Q4 2023, with significant reductions in research and development and administrative expenses.