Acurx Pharmaceuticals is making strides in the development of a new class of antibiotics to combat antibiotic-resistant bacterial infections. The company’s Phase 2b clinical trial for C. difficile infection (CDI) is currently underway, and the FDA has accepted their plan to have an Independent Data Monitoring Committee conduct an interim review of clinical outcomes.
This review will determine whether to terminate the trial early due to success or to continue patient enrollment. These efforts represent a significant step forward in the fight against antibiotic resistance and are critical for the effective treatment of patients with bacterial infections.
At the 33rd Annual European Congress of Clinical Microbiology and Infectious Diseases, Acurx Pharmaceuticals will present a poster showcasing their development of new antibiotics to treat difficult-to-treat bacterial infections such as CDI. Dr. Kevin Garey will lead the presentation, which will focus on the microbiome aspects of the ibezapolstat clinical trial program. Healthcare professionals can stay up to date on the latest developments in the field through this poster presentation.
Ibezapolstat, the novel antibiotic developed by Acurx Pharmaceuticals, targets DNA polymerase IIIC and is a Gram-Positive Selective Spectrum (GPSS) antibacterial that effectively treats bacterial infections, including C. difficile. What’s unique about its spectrum of activity is that it spares other Firmicutes and important Actinobacteria phyla, thereby maintaining a healthy gut microbiome.
The FDA has designated ibezapolstat as a Qualified Infectious Disease Product (QIDP) for treating CDI, which makes it eligible for incentives established under the Generating New Antibiotic Incentives Now (GAIN) Act. The CDC has identified C. difficile as an urgent threat, underscoring the need for new antibiotics to treat CDI. The phase 2 clinical trial for evaluating the efficacy of ibezapolstat in treating CDI includes an open-label single-arm segment (phase 2a) and a double-blind, randomized, active-controlled segment (phase 2b).
CDI is a significant medical problem in hospitals, long-term care facilities, and the community. It is one of the leading causes of healthcare-associated infections in US hospitals, causing nearly 500,000 infections and 20,000 deaths annually. Acurx believes that CDI’s annual incidence in the US is nearly 600,000 infections, with a mortality rate of about 9.3%. Two of the three antibiotics used to treat CDI have a recurrence rate between 20% and 40% among about 150,000 treated patients.
However, Acurx’s ibezapolstat is showing promising results, as phase 2a was completed with ten CDI patients treated orally with 450 mg ibezapolstat twice a day for ten days, followed by recurrence for 28±2 days. Early termination was recommended based on the elimination of infection and no recurrences or adverse events.
The upcoming phase 2b will enroll approximately 64 additional CDI patients, randomized to ibezapolstat or vancomycin for ten days, with an evaluation of PK, microbiome changes, and anti-recurrence microbiome properties. Acurx’s progress in developing a new class of antibiotics to combat antibiotic-resistant bacterial infections, such as CDI, is a significant step forward in ensuring the effective treatment of patients with bacterial infections.
