Acurx Pharmaceuticals, Inc. operates as a clinical stage biopharmaceutical company, which engages in developing new antibiotics for infections caused by bacteria listed as priority pathogens. Its approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme. Its research and development pipeline includes early-stage antibiotic candidates that target other Gram-positive bacteria, including Methicillin-Resistant Staphylococcus aureus, Vancomycin-Resistant Enterococcus and Penicillin-Resistant Streptococcus pneumoniae. The company was founded by David P. Luci, Robert G. Shawah and Robert J. DeLuccia in July 2017 and is headquartered in New York, NY.
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- The USPTO granted Acurx Pharmaceuticals patent US 12,534,470 covering DNA Polymerase IIIC inhibitors, including compositions-of-matter, methods of use, and pharmaceutical compositions. - The patent strengthens Acurx's intellectual property portfolio, bringing their total to four U.S. patents plus international patents in Israel, Japan, India, and Australia. - The company's lead candidate ibezapolstat is Phase 3-ready for C. difficile infection treatment, while preclinical compounds show potential for systemic absorption and broader bacterial infections. - DNA Polymerase IIIC inhibitors target a Gram-positive specific bacterial enzyme, offering a novel approach to combat antibiotic-resistant pathogens including MRSA, VRE, and drug-resistant Streptococcus pneumoniae.
- Acurx Pharmaceuticals has received an Australian patent for its DNA Polymerase IIIC inhibitors, expanding its international intellectual property portfolio to seven patents across multiple countries. - The company's novel antibiotic platform targets multidrug-resistant Gram-positive pathogens including MRSA, VRE, and anthrax using an AI-supported drug discovery approach. - Acurx's lead compound ibezapolstat is Phase 3-ready for C. difficile infection treatment, while preclinical compounds show potential for systemic infections including pneumonia and bacteremia. - The patent protection strengthens the company's position in developing second-generation DNA pol IIIC inhibitors that could transform antibiotic treatment paradigms for difficult-to-treat bacterial infections.
- The European Medicines Agency's Paediatric Committee issued a positive opinion on Acurx's Pediatric Investigation Plan for ibezapolstat use in children with C. difficile infection. - This regulatory milestone fulfills EMA requirements for initiating Phase 3 clinical trials in the European Union and positions the company to begin international trials. - Ibezapolstat demonstrated a 96% clinical cure rate and 100% sustained clinical cure rate in Phase 2 trials, significantly outperforming historical vancomycin outcomes. - The drug represents a novel DNA polymerase IIIC inhibitor that preserves gut microbiome health while treating CDI, addressing the significant unmet need in pediatric populations.
- Acurx Pharmaceuticals received positive guidance from the EMA for its ibezapolstat Phase 3 program, supporting its advancement. - The EMA's feedback included guidance on the regulatory pathway for a Marketing Authorization Application for ibezapolstat in CDI. - Acurx is preparing to request regulatory guidance to initiate clinical trials in Japan, Canada, and the United Kingdom. - Phase 3 trials will assess ibezapolstat's efficacy versus vancomycin in achieving clinical cure and reducing CDI recurrence.
- Acurx Pharmaceuticals presented Phase 2 trial data for ibezapolstat, an investigational antibiotic, at the Peggy Lillis Foundation Inaugural CDI Scientific Symposium. - The study evaluated ibezapolstat versus vancomycin for treating mild to moderate Clostridioides difficile infection (CDI), focusing on microbiome restoration. - Ibezapolstat demonstrated a favorable safety profile with no drug-related serious adverse events or treatment withdrawals reported during the trial. - Results showed high cumulative incidence of unformed bowel movement (UBM) resolution in both treatment groups, suggesting comparable efficacy in resolving diarrhea.
- Acurx Pharmaceuticals presented Phase 2 clinical trial results of ibezapolstat for *C. difficile* infection (CDI) at the Anaerobe Society of the Americas, highlighting its clinical efficacy. - The USPTO granted Acurx a new patent for ibezapolstat, expiring in June 2042, covering the treatment of CDI while reducing recurrence and improving gut microbiome health. - Acurx is planning a Phase 3 clinical program and NDA submission for ibezapolstat, with ongoing preclinical programs for other gram-positive infections like MRSA and VRE. - Phase 2b trial data presented at IDWeek showed ibezapolstat had comparable clinical cure and sustained cure rates to vancomycin, with no recurrence in followed patients.
- Acurx Pharmaceuticals' ibezapolstat demonstrated comparable safety and clinical cure rates to vancomycin in a Phase 2 trial for C. difficile Infection (CDI). - Ibezapolstat treatment led to an increased proportion of beneficial gut bacteria and a higher ratio of secondary to primary bile acids, suggesting potential anti-recurrence effects. - The company is advancing to international Phase 3 clinical trials and seeking regulatory guidance for trials in the EU, UK, Japan, and Canada. - The Phase 2 trial reported a 96% clinical cure rate with no recurrences observed in patients followed for three months post-treatment.
- Acurx Pharmaceuticals reported promising trial results for ibezapolstat, a novel antibiotic targeting Gram-positive bacteria, including Clostridioides difficile. - The studies indicate ibezapolstat's effectiveness in treating colon infections caused by C. difficile without causing cross-resistance with other antibiotics. - Acurx is advancing ibezapolstat to Phase 3 clinical trials for C. difficile infection and is seeking regulatory guidance for trials in the EU, UK, Japan, and Canada. - Given the growing global health crisis of antibiotic resistance, ibezapolstat represents a potential new treatment option, with analysts projecting significant stock upside.
- Acurx Pharmaceuticals announced positive Phase 2 trial results for ibezapolstat in treating C. difficile Infection (CDI), demonstrating a 96% clinical cure rate across Phase 2a and 2b trials. - The Phase 2b trial, initially designed as a non-inferiority study, was amended to include an interim efficacy analysis, influencing the decision to terminate the vancomycin-controlled segment early. - Despite the high cure rate and minimal safety concerns, Acurx's stock price declined by over 30% following the release of the Phase 2 results. - Ibezapolstat's potential advantages include high cure rates, low recurrent infection, minimal microbiome disruption, and manufacturing efficiencies for competitive pricing.
