On behalf Acurx Pharmaceuticals, Altasciences has successfully concluded the clinical conduct, data management and SAS programming for ACX-362E, a novel, oral antibacterial agent for to treat Clostridioides difficile infection (CDI), an acute, severe, potentially life-threatening, intestinal infection.
Altasciences efficiently recruited and retained 62 healthy normal subjects for this first-in-human, randomised, double-blind, placebo-controlled, multiple-ascending dose trial, single and multiple ascending dose phase I study to determine the safety, pharmacokinetics, food and faecal microbiome effects of ACX-362E administered orally to healthy subjects which had a secondary objective to determine the faecal microbiome effects of ACX-362E compared to those of oral vancomycin.
Dr Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for the microbiome aspects of the trial presented the study results at last week’s IDWeek™ Scientific Conference as a “Late-Breaker presentation.”
Dr Garey concluded: “The safety data from the Phase 1 trial are impressive with faecal concentrations comparable to those observed with precedent products that have advanced to demonstrate clinical success. Most notable is the ground-breaking comparison of the effects of ACX-362E versus the standard of care on the normal human gut microbiome.
“Microbiome analysis demonstrated that ACX-362E has a significantly more favourable effect than oral vancomycin due to less disruption of the microbiota in the gastrointestinal tract. This differential was especially pronounced among the phyla, Bacteroidetes and Firmicutes which generally comprise up to 90% of the healthy human gut microbiome.”
The trial, conducted at Altasciences’ clinical pharmacology unit in the USA, provided the first evidence of human safety in single and multiple ascending doses and a favourable PK profile.
Faecal concentrations exceeded those known to inhibit C difficile several hundred-fold, and blood levels showed low systemic exposure, indicating poor oral absorption as desired to treat CDI.
Angela Phillips, Altasciences’ Senior Director of Clinical Operations said: “We are pleased to have partnered with Acurx Pharmaceuticals to advance a new treatment for this serious, potentially life-threatening, intestinal infection that could change the lives of affected patients. Altasciences’ decades of experience in study participant recruitment and first-in-human trials helped deliver timely results that support the development of effective treatments, such as ACX-362E.”
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