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news.Rib-X Pharmaceuticals has initiated a Phase 2b clinical trial to evaluate delafloxacin for the treatment of acute bacterial skin and skin structure infections (ABSSSI), as well as infections caused by methicillin-resistant Staphylococcus aureus (MRSA).
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The trial is designed to evaluate multiple objective efficacy measures in order to support the design of the Phase 3 clinical studies.
The randomised, double blind, Phase 2b study will evaluate delafloxacin versus linezolid and vancomycin using objective efficacy measures to assess relative clinical responses in subjects with ABSSSI.
The trial will enroll 240 subjects across multiple centres in the US, who will be randomised into three equally sized treatment cohorts to receive either delafloxacin 300mg every 12 hours, or recommended doses of linezolid or vancomycin.
The primary endpoints of the study are to assess the relative clinical response to delafloxacin, linezolid, and vancomycin.
The primary endpoints also include evaluating the utility, variability, and measurement techniques of several objective measures of clinical efficacy for use in future clinical trials.
Delafloxacin, a novel fluoroquinolone antibiotic candidate that offers both IV and oral versatility, has successfully completed three Phase 2 clinical trials.