Rib-X Pharmaceuticals, Inc., a biopharmaceutical company developing new antibiotics to provide superior coverage, safety and convenience for the treatment of serious and life-threatening infections, announced positive top-line results from the company’s Phase 2b clinical trial of delafloxacin for the treatment of acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA). Delafloxacin met or exceeded primary and secondary efficacy endpoints evaluated to date in comparison to Zyvox (linezolid), with and without aztreonam, and vancomycin, with and without aztreonam, including endpoints based on the draft guidance from the US Food and Drug Administration (FDA) in ABSSSI. Of note, for the primary endpoint of Investigators’ Global Assessment of Cure, delafloxacin demonstrated statistical superiority in comparison to vancomycin (95% Confidence Interval -30.3%, -2.3%; p=0.031). Based on this top-line analysis and other data, the Company believes delafloxacin has demonstrated a level of efficacy that strongly supports the Company’s planned initiation of a Phase 3 study of delafloxacin in the second half of 2012. Analyses of the full dataset are ongoing and Rib-X plans to present more detailed results at a future scientific meeting.
“It is rare for an antibiotic candidate to demonstrate statistical superiority in a clinical trial, let alone in a Phase 2b study,” said William D. O’Riordan, MD, FACEP, Medical Director, E Study Site and a lead investigator in the study. “Given delafloxacin’s demonstrated broad spectrum of coverage, including MRSA, and IV-to-oral dosing regimens, I believe delafloxacin could be a much needed addition to the antibiotic treatment armamentarium. This is especially important for physicians in the emergency department who need empiric front-line treatments that not only offer a broad spectrum of coverage, but also offer ease of dosing, good tolerability and the potential for lower overall treatment costs, reduced hospital stays and improved patient outcomes.”
Date: December 14, 2011
Source: Rib-X Pharmaceuticals, Inc.
