#Japan #Ibezapolstat #Staten Island #Acurx Pharmaceuticals #DNA Polymerase IIIC

Acurx Pharmaceuticals Makes Headway in Antibiotic Innovation Through New Patent in Japan

Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a biopharmaceutical company in the late stages of developing novel small molecule antibiotics, has recently announced a significant achievement in expanding its intellectual property portfolio. In January 2025, the Japanese Patent Office granted Acurx a patent that pertains to DNA Polymerase IIIC inhibitors. This patent encompasses a range of applications, including pharmaceutical compositions and surface coatings that are designed to treat Gram-positive bacterial infections.

This development is part of Acurx’s ongoing efforts to safeguard its proprietary technologies in the antimicrobial sector. Notably, the company has already secured three patents in the United States, one in Israel, and now this new patent in Japan. These patents are centered around ACX-375C, a program focused on DNA Polymerase IIIC inhibitors, and additional patent applications are underway in other countries.

Robert J. DeLuccia, the Executive Chairman of Acurx, commented on the importance of this patent, which complements their existing global patent estate. The company’s lead candidate, ibezapolstat, is currently preparing for Phase 3 trials aimed at treating and preventing recurrences of Clostridium difficile infections (CDI). DeLuccia emphasized that the patent is timely and plays a crucial role as Acurx advances its AI-driven drug discovery platform, which is focused on second-generation DNA Pol IIIC inhibitors.

The company has also made strides in regulatory guidance, having received positive feedback from the European Medicines Agency (EMA) regarding its Phase 3 program for ibezapolstat. The feedback confirmed that the submitted clinical, non-clinical, and Chemistry Manufacturing Controls (CMC) information supports the advancement of their clinical trials. This is particularly relevant as Acurx overhauls its drug development trajectory with a commitment to combat serious bacterial infections, a field that remains critically under-resourced.

Clinical Trials and Findings

The efficacy of ibezapolstat was first demonstrated in a comprehensive Phase 2 clinical trial, which was conducted across multiple American clinical sites. The study entailed a double-blind, randomized, active-controlled format and included significant participant rounds to ensure robust results. Preliminary findings indicated a high clinical cure rate of 96% in the patient population suffering from CDI. Participants treated in both trial segments showed favorable outcomes that highlighted the antibiotic's effectiveness against this relentless bacterium, as well as a safety profile that was deemed clinically acceptable.

In addition to its efficacy, researchers analyzed the impact of ibezapolstat on the microbiome of infected patients. Early results indicated that the treatment led to desirable changes in bile acid metabolism, which may improve gut microbiota health and contribute to reducing the risk of CDI recurrence. The favorable ratio of secondary to primary bile acids observed during treatments suggests potential advantages for patients treated with ibezapolstat compared to traditional antibiotics like vancomycin.

Market Context and Future Implications

The clinical landscape for CDI remains dire, with current estimates suggesting high annual incidence rates coupled with significant mortality rates associated with infections; the CDC has classified CDI as an urgent public health threat. Acurx Pharmaceuticals, with its innovative approach to antibiotic development, is in a unique position to address these urgent needs. By focusing on selective Gram-positive antibiotics, the company aims to minimize collateral damage to the microbiome, thereby fostering better patient outcomes and decreasing the chances of recurrence—a common setback in CDI treatment.

As Acurx prepares for international Phase 3 trials slated to commence in the upcoming year, the confidence in their clinical advancements, regulatory support, and strong patent protections position them favorably in the competitive biopharmaceutical landscape.

Ultimately, the recent patent granted in Japan not only solidifies Acurx's commitment to forward-thinking antibiotic solutions but also delivers hope for patients confronting these challenging infections. With well-planned studies and ongoing regulatory dialogues, the company seeks to make significant strides in addressing one of healthcare's growing antimicrobial challenges. Acurx Pharmaceuticals, through innovations like ibezapolstat, remains poised to contribute significantly to future antibiotic therapies, thus paving the way for a healthier tomorrow.