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Cempra Provides Guidance on the Clinical Program Required for Regulatory Approval for Solithromycin for Community-Acquired Bacterial Pneumonia (CABP)
Date:6/13/2013

Port IV CABP will be randomized to either a 400 mg IV dose of solithromycin or 400 mg IV dose of moxifloxacin. The investigator will switch patients to oral administration of the assigned antibiotic (solithromycin or moxifloxacin) based on protocol-defined clinical criteria. Patients randomized to solithromycin will receive an 800 mg loading dose on the first day of oral administration followed by 400 mg once daily for a total of seven days of treatment, while patients randomized to moxifloxacin will receive 400 mg once daily for a total of seven days of treatment.

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
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SOURCE Cempra, Inc.
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