Phase 2b study of delafloxacin for the treatment of acute bacterial skin and skin structure infections (ABSSSI)
Rib-X Pharmaceuticals announced the initiation of a Phase 2b trial to evaluate delafloxacin for the treatment of acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA). This study will be a randomized, double-blind comparison of delafloxacin, linezolid, and vancomycin. The study will utilize objective efficacy measures to evaluate the relative clinical responses in subjects with one of the following four types of ABSSSI: cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection. The primary endpoints for the study are to assess the relative clinical response to delafloxacin, linezolid and vancomycin and to assess the utility, variability, and measurement techniques of several objective measures of clinical efficacy for use in future clinical trials.
Delafloxacin is a next-generation fluoroquinolone with a broad spectrum of activity, including potent activity against quinolone-resistant Gram-positive bacteria and MRSA. Both oral and IV formulations have been developed for this compound. Delafloxacin has successfully completed three Phase 2 clinical studies and has been studied in approximately 1,000 subjects.
For more information call (203) 624-5606 or visit www.rib-x.com.