Business
Acurx Announces Positive Extended Clinical Cure Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients
In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI
About this update from Acurx Pharmaceuticals, Inc.
[{"type":"text","content":"In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI experienced no recurrence of infectionFurther analyses will be forthcoming as data become available regarding effects on bile acid metabolism and pharmacokinetic dataPreparation is underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trialsIbezapolstat has previously received FDA QIDP and Fast-Track DesignationSTATEN ISLAND, N.Y., Jan. 29, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (\"Acurx\" or the \"Company\"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 12 patients who agreed to be followed up to three months following Clinical Cure of their infection, 5 of 5 IBZ patients experienced no recurrence of infection. In the vancomycin control arm of the trial, 7 of 7 patients experienced no recurrence of infection. ECC success is defined as a clinical cure at the TOC visit (i.e., at least 48 hours post EOT) and no recurrence of CDI within the 56 ± 2 days post EOT (ECC56) and 84 ± 2 days post EOT (ECC84) in patients who consented to extended observation.\n\nAccording to Dr. Garey: \"CDI has long-term consequences including poor quality of life for the patient. It's exciting to see that the ibezapolstat Phase 2b study followed patients for an extended time period to assure that the ibezapolstat cure and anti-recurrence effects are long-lasting and durable. This adds to the exciting microbiome data showing replenishment of healthy microbiota that we have seen in our prior studies.\"\nRobert J. DeLuccia, Executive Chairman of Acurx, stated: \"This Extended Clinical Cure data showing that no ibezapolstat-treated patient who achieved Clinical Cure and consented to three months of post-treatment observation experienced a recurrence of CDI during this period further strengthens the ibezapolstat lineage of clinical success building on our previously reported P...