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Acurx Pharmaceuticals recently announced positive results in a phase II clinical trial of a new antibiotic, a DNA polymerase IIIC inhibitor called ibezapolstat, used to treat CDI (Difficult Thoresium infection).
DNA pol IIIC is found only in certain Geland-positive bacteria and plays a key role in bacterial replication and disease.
Part A of the Phase II trial recruited 20 patients with diarrhea caused by Thyrobacteria, and 10 patients were assessed 10 days after completion of treatment by taking 450 mg ibezapolstat orthopaedics.
results showed that all 10 patients who participated in the trial reached the end of the study's primary and secondary efficacy: after treatment, all 10 patients were cured and did not relapse within 28 days.
and ibezapolstat has good tolerance and no serious adverse events (SAEs) are reported.
Lead Researcher Dr. Garey stressed that an ideal oral CDI antibiotic must have several key characteristics: high levels of selectivity against Thyrobacteria, safety, and colon non-absorption (which leads to high colon concentrations).
Garey said: "The overall goal of treating CDI is to kill Thyrobacteria and restore a healthy microbiome environment.
Ibezapolstat inhibits the regeneration of deformed bacteria, thus reducing the likelihood of recurrence.
this is consistent with Period II A data, which shows no recurrence 30 days after the initial cure.
2018, the U.S. Food and Drug Administration (FDA) awarded ibezapolstat the Title of Qualified Infectious Disease Products (QIDP) as oral therapy for CDI patients.
the designation of QIDP means that ibezapolstat is "priority review" and eligible to authorize "fast track".