Patent Filed for Application of Ibezapolstat in the Treatment of C. Difficile Infection
Acurx Pharmaceuticals has filed a provisional patent application with the United States Patent and Trademark Office for the use of ibezapolstat in the treatment of Clostridioides difficile (C. difficile) Infection (CDI). This action follows a recently completed phase 2a clinical trial, which demonstrated that 100% of the 10 enrolled patients met the study's primary and secondary efficacy endpoints of clinical cure at end of treatment as well as sustained clinical cure with no recurrence of CDI when examined on a 28-day follow-up visit.
“We believe that ibezapolstat's Gram-Positive Selective Spectrum (GPSS), kills C. difficile, but not other Firmicutes necessary for maintaining a healthy microbiome, and it spares the important Actinobacteria phylum needed for maintaining a healthy microbiome,” said Robert J. DeLuccia, executive chairman of Acurx, in a press release. “This concept of a dual-effect treatment which includes bactericidal activity against C. difficile bacteria, while at the same time providing a restorative effect on the microbiome, has the potential to position ibezapolstat as an important first-line therapy for CDI.”
The phase 2 clinical trial intended to evaluate the use of ibezapolstat in the treatment of CDI is comprised of 2 parts. The first is a multicenter, open-label single-arm segment, which will be followed by a double-blind, randomized, active-controlled segment. In the initial segment, all 10 patients with diarrhea caused by CDI were treated with ibezapolstat 450 mg orally, twice daily for 10 days, and were followed for recurrence for 28 days. After treatment was completed, the trial oversight committee assessed patient safety and tolerability, and based on the results of the trial, the scientific advisory board for Acurx made the decision to terminate enrollment in phase 2a early in favor of advancing to phase 2b.
In phase 2b, approximately 64 additional patients with CDI will be enrolled and evenly randomized to either receive ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours for 10 days, with follow-up examination at 28 days following the end of treatment for recurrence.
According to Acurx, estimates suggest CDI affects nearly 500,000 individuals in the United States annually, and is associated with approximately 20,000 deaths each year. Although C. difficile can sometimes be a normal component of a healthy gut microbiome, if the microbiome is thrown out of balance, the C. difficile can thrive and result in an infection. C. difficile produces the 2 clostridial toxins A (TcdA) and B (TcdB) upon infection, which bind to human intestinal epithelial cells, resulting in inflammation, fluid and mucous secretion, and damage to the intestinal mucosa.
Acurx Announces Filing of Provisional Patent Application for Ibezapolstat to Treat CDI While Reducing Recurrence of Infection and Improving the Health of the Gut Microbiome [news release]. Acurx Pharmaceuticals; July 7, 2021. Accessed July 9, 2021. https://prnmedia.prnewswire.com/news-releases/acurx-announces-filing-of-provisional-patent-application-for-ibezapolstat-to-treat-cdi-while-reducing-recurrence-of-infection-and-improving-the-health-of-the-gut-microbiome-301326841.html