Treatment for C difficile Shows Promising Potential in First-in-Human Phase 1 Trial

A first-in-human trial evaluating the safety, pharmacokinetics, and fecal microbiome effects of a novel DNA polIIIC inhibitor demonstrated the antibacterial’s promise as a potential treatment alternative to vancomycin for the treatment of Clostridioides difficile.

A first-in-human trial evaluating the safety, pharmacokinetics, and fecal microbiome effects of a novel DNA polIIIC inhibitor demonstrated the antibacterial’s promise as a potential treatment alternative to vancomycin for the treatment of Clostridioides difficile.

In a presentation at IDWeek 2019, a team of investigators detailed the 3-part phase 1, double-blind, randomized healthy volunteer trial of the narrow-spectrum antibacterial ACX-362E.

The trial evaluated the safety profile, food effect, and systemic/stool pharmacokinetics of escalating single (150, 300, 600, and 900 mg) and multiple (300 and 450 mg) doses oral ACX-362E compared with placebo. Investigators observed no moderate, severe, cumulative, or dose-limiting adverse events leading to discontinuation, and ACX-362E was generally well-tolerated at all dose levels.

Read the full article by our sister publication, Contagion, at ContagionLive.com.