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Rib-X Pharmaceuticals Announces Positive Phase 2 Study Results for Delafloxacin and a $25 Million Financing
Date:1/26/2009

g BID TIG 50 mg BID Clinically Evaluable 97.2% 92.5% 91.2% p = 0.35* p = 1.00* Modified Intent-to-Treat 89.8% 90.2% 82.0% p = 0.39* p = 0.26* * p value for comparison between DFX and TIG group

In this trial, delafloxacin was safe and well tolerated. Lower rates of overall treatment-related adverse events were noted in both 300 mg BID and 450 mg BID dose groups compared to tigecycline. The most common adverse events reported in the trial were mild and gastrointestinal in nature. Specifically, delafloxacin had notably lower rates of nausea and vomiting as compared to tigecycline.

Prior Clinical Trials with Delafloxacin

The oral formulation of delafloxacin has been evaluated in two successful Phase 2 studies. In one study, delafloxacin was effective at doses as low as 200 mg once daily in patients with community-acquired pneumonia (CAP). In the second study, conducted in patients with acute bacterial exacerbation of chronic bronchitis (ABECB), delafloxacin, at a once a day dose of 200 mg for 5 days, was as efficacious as levofloxacin, 500 mg once daily for 7 days.

About cSSSI

Complicated skin and skin structure infections encompass a wide range of serious infections involving the deeper soft tissue, including severe cellulitis and major abscesses. These infections may occur in patients with skin ulcers or burns, as well as patients who have undergone surgery or experienced other kinds of trauma. These infections affect over one million patients in the U.S. annually and are most commonly caused by Gram-positive bacteria, specifically Staphylococcus aureus and methicillin-resistant S. aureus (MRSA).

About Delafloxacin

Delaflo
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SOURCE Rib-X Pharmaceuticals, Inc.
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