Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) is making strides in the development of ibezapolstat, a novel antibiotic aimed at treating Clostridioides difficile infection (CDI). The company presented promising Phase 2 clinical trial results and secured a key patent, while also outlining plans for Phase 3 trials and a New Drug Application (NDA) submission.
Ibezapolstat Phase 2 Data and Patent Grant
In July 2024, Acurx presented data from its Phase 2 clinical trial of ibezapolstat at the 17th Biennial Congress of the Anaerobe Society of the Americas. Taryn A. Eubank, PharmD, BCIDP, Research Assistant Professor, University of Houston College of Pharmacy, delivered an oral presentation entitled: "Clinical Efficacy of Ibezapolstat in CDI: Results from Phase 2 trials." The results highlighted the potential of ibezapolstat in treating CDI.
Also in July, the United States Patent and Trademark Office (USPTO) granted Acurx a new patent for ibezapolstat. This patent specifically covers the "treatment of C. difficile Infection while reducing recurrence of infection and improving the health of the gut microbiome" and is set to expire in June 2042. The company believes this patent will provide a significant competitive advantage.
Regulatory and Clinical Pathway
Acurx submitted a request to the FDA in August 2024 for a meeting to review manufacturing processes and specifications for ibezapolstat. This "CMC Meeting" is a customary step before commencing Phase 3 clinical trials. The company anticipates convening this meeting with the FDA in the fourth quarter.
In September 2024, Executive Chairman Bob DeLuccia presented at the World Antimicrobial Resistance Scientific Congress in Philadelphia, outlining a complete roadmap for the Phase 3 clinical program and the subsequent NDA filing. He also provided an update on the company's preclinical GPSS® (Gram Positive Selective Spectrum) program for systemic oral and IV treatment of other gram-positive infections, including MRSA, VRE, and DRSP.
Further Research and Development
Also in September 2024, Acurx participated in the 8th Annual C. Difficile Symposium (ICDS) in Bled, Slovenia, where two presentations were made on behalf of the company. Additionally, selected ACX-375 DNA pol IIIC analogues demonstrated in vitro activity against B. anthracis (Anthrax), including activity against ciprofloxacin-resistant Anthrax. Planning is underway for an Anthrax bioterrorism development program.
IDWeek Presentation
In October 2024, at IDWeek in Los Angeles, Drs. Kevin Garey and Taryn Eubank presented a scientific poster showing that in the Phase 2b clinical trial, ibezapolstat had comparable clinical cure and sustained clinical cure rates and safety profile to vancomycin. Furthermore, 5 of 5 ibezapolstat patients who were followed for 3 months after end of treatment (EOT) experienced no recurrence. The study also indicated that ibezapolstat-treated patients showed decreased concentrations of fecal primary bile acids and higher ratios of secondary to primary bile acids than vancomycin-treated patients.
Financial Position
The company ended the third quarter of 2024 with $5.8 million in cash, compared to $7.5 million as of December 31, 2023. Research and development expenses for the three months ended September 30, 2024, were $1.2 million, compared to $1.3 million for the same period in 2023. The company reported a net loss of $2.8 million, or $0.17 per diluted share, for the three months ended September 30, 2024.
About Ibezapolstat
Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI.
