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news.Rib-X Pharmaceuticals, a developer of new antibiotics for the treatment of antibiotic-resistant infections, has announced positive top-line results from a Phase II clinical trial with the intravenous form of its novel anionic quinolone antibiotic, delafloxacin.
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The double-blind study showed that both doses (300mg BID and 450mg BID) of delafloxacin were as efficacious as the FDA approved dosing regime for tigecycline in the treatment of complicated skin and skin structure infections (cSSSI).
Additionally, when evaluated in vitro against the gram-positive and gram-negative organisms isolated from patients within this trial, delafloxacin was shown to be the more active compound overall, including its activity against Staphylococcus aureus and methicillin-resistant S aureus and quinolone-resistant gram-positive pathogens.
This Phase II double-blind study evaluated the safety and efficacy of delafloxacin dosed intravenously at 300mg and 450mg twice a day to patients with cSSSI for five to 14 days, as compared to the FDA approved dosing regime for tigecycline for the same time period.
Susan Froshauer, president and CEO of Rib-X Pharmaceuticals, said: “This is the third Phase II clinical trial showing delafloxacin to be both efficacious and safe. The data for delafloxacin continues to show that this broad spectrum compound is likely to be a valuable tool in the armamentarium of agents for treatment of resistant bacterial infections.”