"We are extremely encouraged by the final results of this third Phase 2 trial, which affirm delafloxacin's safety and show its broad spectrum activity in difficult-to-treat complicated skin infections," said Susan Froshauer, Ph.D., President and CEO of Rib-X Pharmaceuticals. "Delafloxacin proved to be the more active compound compared to tigecycline when evaluated against both Gram-positive and Gram-negative bacterial isolates from patients, including MRSA and quinolone-resistant MRSA and other organisms. Additionally, this drug has the potential for IV use in the hospital with an oral step down."
"Rib-X starts off 2009 extremely well positioned to proceed with advancing delafloxacin towards Phase 3 trials," continued Dr. Froshauer. "We not only have excellent Phase 2 results for one of our key compounds, but we also have the commitment of our investors, and we would like to thank them for their continued support."
Phase 2 Study Design and Results
This Phase 2 double-blind study evaluated the safety and efficacy of delafloxacin at two intravenous doses, 300 mg BID and 450 mg BID, compared to tigecycline (TYGACIL(R), Wyeth Pharmaceuticals), in adults with cSSSI. Treatment duration was 5 to 14 days. Of the 150 patients randomized in this trial, 68% were male; the mean age was 40+/-14.5 years. 36% had cellulitis, 31% had wound infections and 33% had abscesses. 111 (74%) patients had pathogens identified at baseline, with 96 identified as S. aureus.
The clinical cure rates in the Clinically Evaluable and Modified Intent-to-Treat populations are presented below:
Percent Clinical Cure at TOC Population DFX 300 mg BID DFX 450 m
|SOURCE Rib-X Pharmaceuticals, Inc.|
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