Acurx Pharmaceuticals Inc (NASDAQ: ACXP) is developing novel antibiotics to treat bacterial infections, announced the data from Phase I trial, and indicated a lower risk of recurrence of Clostridioides difficile Infection (CDI) with Ibezapolstat in comparison to Vancomycin.
Commencing Phase 2 trial: After the success of Phase I, Acurx Pharmaceuticals is expected to commence the Phase 2 trial in a patient with Clostridioides difficile Infection. As per Phase I, Ibezapolstat result in a sharp increase in Proteobacteria and Fusobacterium.
The superiority of Ibezapolstat in comparison to Vancomycin, were present by Dr. Kevin Garey, Principal investigator of the clinical trial program. The data from Phase I indicates a distinctive microbiome signature, which increases the growth of Actionobacteria without promoting the overgrowth of Proteobacteria. The outcome indicates Ibezapolstat success, which is expected to have a “restorative” impact on the microbiome. The management sounded quite confident and stated that phase 2a clinical trial outcome is expected to supplement the hypothesis and give successful results. Phase 2a clinical trial is expected to commence in the latter part of the year (2021).
Novel Approach: The OMICS approach is an extensive study to quantify biological molecules and characterize them to understand an organism’s function and structure, involving microbiome analysis and determination of bile acid concentration. The study’s outcome is expected to enable earlier prediction of anti – Clostridioides difficile Infection recurrence for antibiotics during the development stage. The hypothesis is expected to be tested in the phase 2a trial later this year. Furthermore, as per the data published after the phase 1 trial, it is indicated that in an early stage of development of Ibezapolstat. Thus, it can create a new stage for Clostridioides difficile Infection drug development.