The primary outcome analysis in both Phase 3 trials is non-inferiority (NI) in the early clinical response rates (ECR). ECR is defined as improvement at 72 hours after the first dose of study drug, in at least two of the following four symptoms: cough, shortness of breath, chest pain and sputum production in the Intent-To-Treat (ITT) population. Each study is designed to provide 90 percent power to demonstrate NI in ECR rates of solithromycin versus moxifloxacin utilizing a 10 percent margin. A co-primary outcome analysis will assess NI in ECR rates in the pooled microbiological ITT (mITT) population from the two studies. Secondary endpoints include the clinical success rate at the short-term follow-up visit five to ten days following the last dose of study drug in the ITT and clinically evaluable populations, and a comparison of safety and tolerability of solithromycin compared to moxifloxacin.
A single Phase 3 study of solithromycin in uncomplicated gonococcal infection would likely be sufficient if the Phase 3 CABP trials are successful. This study would be planned to include 250 patients who receive solithromycin, of which 150 are males. Treatment of Chlamydia may be included as a secondary endpoint. The specific protocol remains under discussion.
On June 12, 2013, the FDA issued a proposed rule listing pathogens that would be eligible for drug development incentives under
|SOURCE Cempra, Inc.|
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