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Cempra Slips on Phase 3 Results

Cempra Inc. (NASDAQ CEMP) made waves in the market on Friday morning on Phase 3 trial news. The company announced positive top-line results from a global, pivotal Phase 3 clinical trial of intravenous (IV) to oral solithromycin (Solitaire-IV) in the treatment of patients with community-acquired bacterial pneumonia (CABP).

In the intent-to-treat population, solithromycin met the FDA primary objective of statistical non-inferiority compared to moxifloxacin at the early clinical response.

Solithromycin also met the co-primary objective of statistical NI compared to moxifloxacin at the ECR in the microbiological ITT (mITT) population (those patients with an etiologic diagnosis of the cause of CABP)...


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