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Acurx Pharmaceuticals Announces Positive In-Silico Results for Ibezapolstat

Acurx Pharmaceuticals, Inc. has made significant strides in the treatment of Clostridioides difficile Infection (CDI) through recent in-silico findings on its leading antibiotic candidate, ibezapolstat (IBZ). This biopharmaceutical company, renowned for its innovative approach to challenging bacterial infections, is advancing towards international Phase 3 clinical trials for IBZ, marking a pivotal step in its quest to tackle CDI, a prevalent and serious health issue.

Understanding the Study

The pivotal study titled "The Microbiome-restorative Potential of Ibezapolstat for the Treatment of Clostridioides difficile Infection is Predicted Through Variant PolC-type DNA Polymerase III in Lachnospiraceae and Oscillospiraceae" has recently been published in the Journal of Antimicrobial Agents and Chemotherapy. Dr. Jacob K. McPherson, a PharmD and PhD candidate at the University of Houston, led the research, which was funded by the National Institute of Allergy and Infectious Diseases.

This study primarily focuses on the mechanism behind ibezapolstat's selectivity in combating CDI, providing a comprehensive explanation for its bactericidal interactions, particularly in the Bacillota phylum, which includes C. difficile. More encouragingly, it was found that certain beneficial bacterial taxa exhibit natural resistance to ibezapolstat, allowing them to thrive and regrow during treatment, thus promoting a healthier microbiome during and after antibiotic therapy.

Findings and Implications

Co-author and microbiology expert, Dr. Kevin Garey from the University of Houston College of Pharmacy, pointed out that these findings are crucial in understanding the unexpectedly narrow activity spectrum observed in previous clinical trials. He elaborated that genomic differences in PolC among various species influence the binding of ibezapolstat, protecting beneficial microbes while effectively targeting harmful bacteria like C. difficile. This approach contrasts sharply with traditional antibiotics like vancomycin, which are known to decimate beneficial gut microbes, thereby increasing recurrence rates of CDI.

Acurx's Executive Chairman, Bob DeLuccia, emphasized the importance of this in-silico genomic analysis in conjunction with their ongoing structural biology studies in partnership with Leiden University Medical Center, asserting confidence that this will not only benefit the ibezapolstat program but also their systemic antibiotic discovery initiatives.

Advancing Toward Phase 3 Trials

With regulatory support from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), Acurx is well-positioned to commence international Phase 3 trials. The preparation includes two planned trials designed to assess IBZ's efficacy against standard care with a focus on clinical cure rates and recurrence prevention among patients suffering from CDI.

The rigorous design encompasses a randomized control format involving approximately 450 subjects, split between ibezapolstat and vancomycin, with comprehensive monitoring over extended periods to ensure reliable data collection on effectiveness and safety. The trials aim not only to measure immediate clinical outcomes but also to observe the long-term implications on gut health and recurrence rates.

The Importance of Ibezapolstat

Ibezapolstat represents a groundbreaking approach in the antibiotic space, striving to mitigate the impact CDI has on public health. Given CDI's alarming prevalence, estimated at nearly 500,000 infections annually in the U.S. alone, ibezapolstat’s design as a Gram-Positive Selective Spectrum (GPSS) agent specifically targeting harmful bacteria while maintaining beneficial ones positions it as a potential game-changer in antibiotic therapy. The onset and data emerging from initial Phase 2 studies showcase notable success, with a reported clinical cure rate of around 96% among treated patients.

Moreover, favorable alterations in bile acid metabolism observed during ibezapolstat therapy align with its designed efficacy in reducing recurrence risks, further setting Acurx apart from traditional antibiotic approaches.

Conclusion

As Acurx Pharmaceuticals continues its expedition to refine and bring ibezapolstat into clinical use, the latest research outcomes validate the promising potential for both immediate and longitudinal health benefits in patients afflicted with CDI. This innovative therapy promises not only to treat infections more effectively but also endeavors to restore the delicate balance of the gut microbiome, asserting its significance in the growing battle against antibiotic resistance and recurring infections.

For more information, visit Acurx's official website at www.acurxpharma.com.