Acurx’s ibezapolstat granted end of Phase 2 meeting by FDA, EMA SME designation

Acurx announced that an EOP2 meeting has been granted by FDA to discuss the overall Phase 3 clinical and non-clinical development plan to support an NDA filing for ibezapolstat for the treatment of CDI. The company submitted its Meeting Request earlier this month following successful completion of ibezapolstat’s Phase 2 clinical trial. On February 14, the FDA granted an EOP2 meeting which confirms adequate information was provided to warrant this type of meeting. Additionally, the company was granted SME designation by the European Medicines Agency on February 15, which allows Acurx to benefit from fee incentives and other support from the EMA for conduct of required clinical trials for ultimate EU Marketing Authorization. The SME designation was established by EMA to promote innovation and the development of new medicinal products by smaller companies. Companies with SME status are eligible to receive financial incentives as well as administrative and regulatory support through national and regional level programs.