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Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) is a late-stage biopharmaceutical company specializing in developing innovative antibiotics designed to combat drug-resistant bacterial infections. The company's leading drug candidate, ibezapolstat, is an orally administered antibiotic developed to treat Clostridioides difficile infections (CDI), a serious and life-threatening condition. Acurx is advancing ibezapolstat to Phase 3 clinical trials to establish its efficacy and safety compared to standard treatments such as vancomycin.
Ibezapolstat works by targeting the Gram-Positive Selective Spectrum (GPSS®) and inhibiting the DNA polymerase IIIC enzyme critical for bacterial replication in Gram-positive bacteria. This mechanism not only effectively treats the infection but also preserves the healthy gut microbiome, thus reducing the likelihood of infection recurrence. Acurx’s studies have shown promising results, including a 96% clinical cure rate and excellent microbiome preservation, establishing non-inferiority to vancomycin.
The company has received multiple designations from the FDA, including Qualified Infectious Disease Product (QIDP) and Fast Track status, which highlight the urgent need for new antibiotics to treat CDI. These designations facilitate expedited development and review processes, enabling faster patient access to new treatments.
Recent progress includes the successful completion of a Phase 2b clinical trial, which demonstrated high clinical cure rates and no recurrence of infection in patients treated with ibezapolstat. The company has also reached critical milestones with regulatory agencies, including the FDA and EMA (European Medicines Agency), paving the way for international Phase 3 trials.
Acurx is committed to addressing the growing threat of antibiotic resistance. The company’s R&D pipeline includes additional antibiotics targeting other serious Gram-positive bacterial infections, such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and drug-resistant Streptococcus pneumoniae.
Acurx Pharmaceuticals (NASDAQ: ACXP) presented results from the ibezapolstat Phase 2 clinical trial for C. difficile Infection (CDI) at the 17th Biennial Congress of the Anaerobe Society of the Americas. The study showed favorable gut microbiome changes, including increased Actinobacteria in treated patients. Results were consistent with earlier studies, demonstrating preservation of beneficial bacteria. Dr. Kevin Garey highlighted the robust microbiome development plan, predicting an anti-recurrence effect of ibezapolstat. The company is preparing for Phase 3 clinical trials following a successful FDA End-of-Phase 2 Meeting, with plans to expand internationally.
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.
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