Acurx Presents Positive Ibezapolstat Microbiome Data from Its Phase 2a Trial at IDWeek
- Category: DNA RNA and Cells
- Published on Monday, 04 October 2021 20:39
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- Patient fecal samples were evaluated for C. difficile culture and microbiome changes
- Ph2a trial demonstrated 100% clinical cure and sustained clinical cure
- Favorable microbiome changes included overgrowth of Actinobacteria and Firmicutes phylum species while on therapy
- Results begin to confirm the microbiome effects seen in Phase 1 healthy volunteers, indicating that microbiome effects may be predictive of beneficial patient outcomes including low rates of recurrence.
STATEN ISLAND, NY, USA I October 4, 2021 I Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that a scientific abstract and poster were presented on September 29th at the Infectious Disease Society of America (IDSA) IDWeek™ 2021 Virtual Conference entitled: "An Open-label Phase 2a study of Ibezapolstat, a Unique Gram-positive Selective Spectrum (GPSS™) Antibiotic, for Patients with Clostridioides difficile Infection." These results were presented by Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for microbiome aspects of the clinical trial program for ibezapolstat.
The Company's upcoming Phase 2b segment of this clinical trial will also evaluate pharmacokinetics (PK) and microbiome changes from baseline and continue to test for anti-recurrence microbiome properties seen in the Phase 1 trial, including the treatment-related changes in alpha diversity and bacterial abundance. The Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment as well as the observed overgrowth of healthy gut microbiota Actinobacteria and Firmicute phyla species during and after therapy. According to Dr. Garey, "The good tolerability, promising efficacy outcomes, minimal systemic exposure, and differential microbiome effects relative to vancomycin all support the continued clinical development of ibezapolstat. He added: "Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. Furthermore, ibezapolstat demonstrated decreased proteobacteria overgrowth in contrast to vancomycin."
Robert J. DeLuccia, Executive Chairman of Acurx, stated, "We are particularly excited by these results in CDI patients which are consistent with the favorable microbiome profile when compared with vancomycin in our earlier Phase 1 healthy volunteer trial. He further stated that "We look forward to beginning enrollment in our Phase 2b trial which will compare ibezapolstat to the standard of care, vancomycin, and is expected to begin enrollment this quarter."
Dr. Garey's E-Poster Scientific Exhibit can be viewed on the company's website www.acurxpharma.com, Tab: News Media, Presentations.
About Clostridioides difficile Infection (CDI). According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate of two of the three antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.
About the Microbiome in Clostridioides difficile Infection (CDI)
C. difficile can sometimes be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.
About the Ibezapolstat Phase 2 Clinical Trial.
The multicenter, open-label single-arm segment of this study (Phase 2a) is to be followed by a double- blind, randomized, active-controlled segment (Phase 2b) which, together, comprise the Phase 2 clinical trial. The Phase 2 clinical trial is designed to evaluate ibezapolstat in the treatment of CDI. Phase 2a of this trial is completed and was an open-label cohort of up to 20 subjects from study centers in the United States. In this cohort, 10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment, the Trial Oversight Committee assessed the safety and tolerability and made its recommendation regarding early termination of the Phase 2a study. Based on the recommendation of Acurx's Scientific Advisory Board (SAB) and Trial Oversight Committee, we terminated enrollment in Phase 2a early and are now advancing to Phase 2b. The SAB unanimously supported the early termination of the Phase 2a trial after 10 patients were enrolled in the trial instead of 20 patients as originally planned. The early termination was based on the evidence of meeting the primary and secondary endpoints of eliminating the infection (100%), with no recurrences of infection (100%), and with an acceptable adverse event profile. In the upcoming Phase 2b, approximately 64 additional patients with CDI will be enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments will be identical in appearance, dosing times, and number of capsules administered to maintain the blind. This Phase 2 clinical trial will also evaluate pharmacokinetics (PK) and microbiome changes and continue to test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy.
About Acurx Pharmaceuticals, Inc.
Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP). To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com.
SOURCE: Acurx Pharmaceuticals