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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, Inc. (NASDAQ: ACXP) recently presented key findings at ECCMID 2023 in Copenhagen regarding its novel antibiotic ibezapolstat. Research showcased ibezapolstat’s unique action against C. difficile infections, demonstrating efficacy against resistant strains. The presentation highlighted positive outcomes from Phase 2a trials, where ibezapolstat achieved 100% clinical cure rates without recurrence. Additionally, updates on the company's preclinical antibiotic program targeting systemic gram-positive infections were provided. Ibezapolstat has already received FDA QIDP and Fast-Track Designation, indicating its potential as a significant treatment for bacterial infections. Acurx is currently enrolling patients for a Phase 2b clinical trial for C. difficile infection.
Acurx Pharmaceuticals announced the FDA's acceptance of its Interim Analysis Plan for an Independent Data Monitoring Committee (IDMC) to evaluate clinical outcomes in its Phase 2b clinical trial of ibezapolstat for treating Clostridioides difficile Infection (CDI) upon reaching 36 patient enrollments. This follows a successful Phase 2a trial, which demonstrated a 100% clinical cure rate. The Company will present findings at ECCMID 2023, including a poster on ibezapolstat's novel pharmacologic properties. The Phase 2b trial is a randomized, double-blind study comparing ibezapolstat to vancomycin, aiming to enroll 64 patients and assess anti-recurrence effects. Ibezapolstat has received QIDP and Fast Track designations from the FDA, highlighting its potential in an urgent therapeutic area. The Company also plans to share updates on its antibiotic pipeline at ECCMID.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported its Q4 and full-year 2022 financial and operational results on March 16, 2023. The Company continues its Phase 2b clinical trial for ibezapolstat, with 25 patients enrolled and an interim data review expected mid-2023. Acurx's cash position decreased to $9.1 million from $13.0 million year-over-year. R&D expenses increased to $4.8 million for 2022, attributed to trial costs. The net loss narrowed to $12.1 million in 2022 from $12.7 million in 2021. The Company awaits a decision on an $11.3 million non-dilutive grant in April 2023.
Acurx Pharmaceuticals (NASDAQ: ACXP) will discuss its financial results for Q4 2022 and full-year 2022 on March 16, 2023, at 8:00 a.m. ET. The call, led by CEO David P. Luci and CFO Robert G. Shawah, follows the successful completion of the Phase 2a trial of ibezapolstat, a new antibiotic for treating Clostridioides difficile infection (CDI). The trial showed 100% infection cure at the end of treatment. The subsequent Phase 2b trial is currently enrolling patients to compare ibezapolstat with vancomycin. This segment will further analyze pharmacokinetics and microbiome changes, potentially reducing CDI recurrence risk.
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