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news.Rib-X Pharmaceuticals has reported the enrollment of the first patients in two separate Phase II clinical trials to evaluate the safety and efficacy of RX-1741 in the treatment of community-acquired pneumonia, and separately in the outpatient treatment of uncomplicated skin and skin structure infections.
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The community-acquired pneumonia (CAP) study is a Phase II, multicenter, randomized, double-blind study, which will assess the efficacy of three doses of RX-1741, either once or twice a day, for seven to 10 days in the treatment of adult patients with mild to moderate CAP. It will also evaluate the safety and tolerability profile of the three doses. The CAP study will enroll approximately 160 patients in 40 study centers across the US, Canada and Russia. The company intends to release data from all patients during the first half of 2008.
The uncomplicated skin and skin structure infections (uSSSI) study is a Phase II, multicenter, randomized, open-label, comparative study to evaluate the safety and efficacy of RX-1741 versus linezolid. The study will assess the efficacy of a single dose of RX-1741 given either once daily or twice daily compared to linezolid given twice daily for five to 10 days in the treatment of ambulatory patients with uSSSI. It will also evaluate the safety and tolerability profile of these two doses compared to linezolid. The uSSSI study will enroll approximately 150 patients in 25 study centers across the US.