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STATEN ISLAND, N.Y. - Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a clinical-stage biopharmaceutical company with a market capitalization of $12.5 million engaged in developing new antibiotics, has been granted a patent by the Japanese Patent Office in January 2025. The company’s stock, currently trading at $0.74, has experienced significant volatility, declining 77% over the past year. According to InvestingPro analysis, the stock appears to be trading near its Fair Value, with analysts setting price targets between $10-12. The patent covers the company’s DNA Polymerase IIIC Inhibitors, vital for its ACX-375C program aimed at treating Gram-positive bacterial infections.
This new patent is a part of Acurx’s broader strategy to establish a global patent portfolio. The company has previously secured three patents in the United States, one in Israel, and is pursuing additional patents in other countries.
Executive Chairman Robert J. DeLuccia emphasized the significance of the patent, highlighting its role in advancing Acurx’s AI-supported drug discovery platform for second-generation DNA pol IIIC inhibitors. These inhibitors are being developed for oral and parenteral use against infections caused by Gram-positive bacteria such as Staphylococcus aureus, including MRSA, and B. anthracis, a pathogen considered a bioterrorism threat.
Acurx’s ibezapolstat, a minimally absorbed oral antibiotic, is now Phase 3-ready for the treatment and prevention of C. difficile Infection (CDI) recurrence. While InvestingPro data shows the company maintains a healthy current ratio of 1.8 and holds more cash than debt, investors should note that analysts don’t expect profitability this year. InvestingPro subscribers have access to 8 additional key insights about ACXP’s financial health and market position. The company has received positive feedback from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), supporting the advancement of the ibezapolstat Phase 3 program and the potential submission of a marketing authorization application in Europe.
The Phase 3 trial will compare ibezapolstat to the standard-of-care vancomycin in a 1:1 randomized design, focusing on Clinical Cure of CDI and the reduction of recurrence. The trial will involve an estimated 450 subjects in the Modified Intent-To-Treat population.
Acurx has reported a 96% Clinical Cure rate in its combined Phase 2 trials for patients with CDI. The company also noted that ibezapolstat was well-tolerated, with only mild, transient gastrointestinal adverse events reported. Additionally, the Phase 2 trials indicated that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin.
Ibezapolstat is recognized by the FDA as a Qualified Infectious Disease Product and has been granted Fast Track designation. CDI is an urgent health threat, with approximately 500,000 infections and 20,000 associated deaths annually in the U.S.
Acurx Pharmaceuticals continues to focus on developing antibiotics targeting difficult-to-treat bacterial infections. The company’s pipeline includes treatments for various Gram-positive bacteria and is preparing to initiate international Phase 3 clinical trials for ibezapolstat. With a beta of -1.72, the stock often moves contrary to market trends, presenting unique opportunities for investors. InvestingPro subscribers can access comprehensive research reports and detailed financial metrics to better understand the company’s development trajectory and market potential.
This article is based on a press release statement from Acurx Pharmaceuticals, Inc.
In other recent news, Acurx Pharmaceuticals, Inc. is advancing its lead antibiotic candidate, ibezapolstat, into Phase 3 trials for Clostridioides difficile Infection (CDI) following positive feedback from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company received confirmation from the FDA regarding the readiness of its Chemistry Manufacturing and Controls (CMC) data package and is set to proceed with non-inferiority studies comparing ibezapolstat to vancomycin. The trials will involve approximately 450 subjects to assess clinical cure rates and potential reductions in CDI recurrence. Acurx’s Phase 2 trials demonstrated a 96% clinical cure rate with a favorable safety profile. In a separate development, Acurx has allocated up to $1 million for Bitcoin as a treasury reserve asset, citing growing institutional support for digital currencies. This move is intended to diversify their treasury strategy without diverting focus from their primary drug development activities. The company emphasizes that the Bitcoin investment is a financial strategy for cash reserves needed over the next 12 to 18 months.
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