LAVAL, Quebec – (BUSINESS WIRE) – Namens de sponsor, Acurx Pharmaceuticals, is Altasciences trots het klinische gedrag, gegevensbeheer en SAS-programmering met succes te hebben voltooid voor ACX-362E, een nieuw, oraal antibacterieel middel voor de behandeling van Clostridioides difficile-infectie (CDI), een acute, ernstige, mogelijk levensbedreigende darminfectie. Altasciences heeft op efficiënte wijze 62 gezonde normale personen aangeworven en behouden voor deze eerste menselijke proef, gerandomiseerde, dubbelblinde, placebogecontroleerde, meervoudig oplopende dosisstudie, enkelvoudige en meervoudige oplopende dosis fase I-studie om de veiligheid, farmacokinetiek, voeding, en fecale microbioomeffecten van ACX-362E oraal toegediend aan gezonde proefpersonen die een secundair doel hadden om de fecale microbioomeffecten van ACX-362E te bepalen in vergelijking met die van orale vancomycine.
Altasciences Conducts Successful First-in-human Trial for Acurx Pharmaceuticals’ Novel Antibiotic to Treat C. Difficile Infection
LAVAL, Quebec–(BUSINESS WIRE)– On behalf of the sponsor, Acurx Pharmaceuticals, Altasciences is proud to have successfully completed the clinical conduct, data management, and SAS programming for ACX-362E, a novel, oral antibacterial agent for the treatment of Clostridioides difficile infection (CDI), an acute, serious, potentially life-threatening, intestinal infection. Altasciences efficiently recruited and retained 62 healthy normal subjects for this first-in-human, randomized, double-blind, placebo-controlled, multiple-ascending dose trial, single and multiple ascending dose phase I study to determine the safety, pharmacokinetics, food, and fecal microbiome effects of ACX-362E administered orally to healthy subjects which had a secondary objective to determine the fecal 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 fecal 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 favorable 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 U.S.A., provided the first evidence of human safety in single and multiple-ascending doses and a favorable PK profile. Fecal 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.”
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements. Altasciences… helping sponsors get better drugs to the people who need them, faster.