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Acurx Pharmaceuticals (NASDAQ: ACXP) has announced the successful conclusion of an FDA End-of-Phase 2 meeting, allowing the advancement of ibezapolstat for the treatment of C. difficile Infection (CDI) to Phase 3 clinical trials. The FDA agreed on key trial elements including protocol design and patient population. The trials will involve 450 subjects using a Modified Intent-To-Treat (mITT) population. Ibezapolstat has received FDA's QIDP and Fast-Track Designation and recently obtained SME designation from the European Medicines Agency, enabling fee incentives for EU Marketing Authorization. Plans include initiating trials in the EU, UK, Japan, and Canada.
Acurx Pharmaceuticals (NASDAQ: ACXP) announced its Q1 2024 financial and operational results, highlighting significant progress in its clinical trials and business operations.
Key achievements include positive data from the Phase 2b trial of ibezapolstat, which showed superior results over vancomycin for treating CDI, with a 94% eradication rate of C. difficile by Day 3. The FDA has agreed on the Phase 3 program and NDA filing pathway. The European Medicines Agency designated Acurx as an SME, providing fee reductions and support.
Financially, Acurx ended Q1 2024 with $8.9 million in cash, up from $7.5 million at the end of 2023. The company reported a net loss of $4.4 million, driven by increased R&D and G&A expenses. 1,121,793 shares were sold under ATM financing, raising $4.4 million.
Further data and presentations are anticipated throughout 2024 at several scientific conferences.
Acurx Pharmaceuticals announced the presentation of the Phase 2 clinical trial results of ibezapolstat for C. difficile Infection at ESCMID Global 2024 Scientific Conference. The results showed ibezapolstat's effectiveness in treating CDI and its potential as a therapeutic option against antimicrobial-resistant strains.