The investigational agent, afabicin, was developed by private company, Debiopharm, and a clinician offers some insights on the therapy in these 2 therapeutic areas.
Debiopharm is a privately-owned, Swiss-based, biopharmaceutical company working on treatments to cure cancer and treat infectious diseases. The company is developing microbiome-sparing pathogen-specific FabI inhibitors, a new class of antibiotics with novel mechanism of action. Afabicin, the most advanced FabI inhibitor in the pipeline, inhibits the fatty acid synthesis in staphylococci by targeting the Fabl enzyme. According to the Debiopharm, the therapy fulfills all 4 World Health Organization’s 2020 innovativeness criteria, including it’s a new chemical class, new target, a new mode of action and no cross-resistance to other antibiotic classes.
Debiopharm reports the compound is currently in phase 2 research for the treatment of bone and joint infections (BJI) due to staphylococci. Afabicin is also being researched in staphylococcal acute bacterial skin and skin structure infections (ABSSSI).
Debiopharm completed a phase 2 study in patients with staphylococcal ABSSSI evaluating the efficacy and safety of this first-in-class staphylococcal-selective antibiotic afabicin, available as intravenous and oral treatment, in comparison to active comparator intravenous vancomycin /oral linezolid. Afabicin was efficacious and well tolerated in the treatment of ABSSSI due to staphylococci and the study objectives were met, demonstrating non-inferiority of afabicin to comparator. The primary efficacy outcome of early clinical response at 48 to 72 h post randomization, as specified in the FDA guidance for ABSSSI, was comparable among treatment groups.
Contagion spoke to Ricardo Chaves, MD, PhD, executive medical director, clinical development, Debiopharm at the recent World AMR Congress and he offered further insights on this investigational antibiotic and the company’s pipeline.