Antibiotic specialist Cempra (Nasdaq: CEMP) has announced positive top-line results from its pivotal Phase III trial of solithromycin oral capsules in the treatment of community-acquired bacterial pneumonia.
Solithromycin met the primary objective of statistical non-inferiority (where the non-inferiority margin was 10%) of the early clinical response at 72 hours after initiation of treatment, compared to moxifloxacin.
It also met the secondary endpoint of non-inferiority in clinical success at the short-term follow up visit at five to 10 days after the end of treatment, in both the intent-to-treat and evaluable populations.
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