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Acurx Pharmaceuticals Inc (NASDAQ:ACXP) released comparative microbiology and microbiome data for ibezapolstat, its lead antibiotic candidate, from its completed Phase 2b trial in patients with Clostridioides difficile Infection (CDI).
Data showed that ibezapolstat outperformed vancomycin, a standard of care to treat patients with CDI, with eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 patients (94%) versus vancomycin, which had eradication of fecal C. difficile in 10 of 14 patients (71%).
In addition, ibezapolstat, but not vancomycin, consistently preserved and allowed the regrowth of key gut bacterial species believed to confer health benefits, including preventing CDI recurrence.
Also Read: Acurx’s Antibiotic Shows All Patients With Clinical Cure Remained Infection-Free After End Of Treatment.
Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days.
Robert DeLuccia, Executive Chairman of Acurx, stated: “These new comparative data are very important and timely to enhance our data package for an end of Phase 2 FDA Meeting which is targeted for second quarter this year.
He further stated: “Parallel preparations continue on schedule for Phase 3 clinical trials start up later this year, including timely availability of clinical trial supply.
David Luci, President & CEO of Acurx, has announced the ongoing success of Ibezapolstat in treating patients with Clostridioides difficile infection (CDI) when compared to the standard oral vancomycin.
Luci expects further positive results in Q1 2024, including extended clinical cure and additional microbiome comparison data.
Acurx plans to capitalize on this success in the $1 billion plus US CDI global market by initiating an international Phase 3 clinical trial. Luci is optimistic about Ibezapolstat’s potential price competitiveness, suggesting it could outperform other recommended antibiotics in terms of clinical effectiveness, microbiome health, safety, and cost for CDI patients, pending approval.
Price Action: ACXP shares are down 25.70% at $3.53 on the last check Wednesday.
Posted In: ACXP
