Cempra gains on Phase III ABSSSIs data

Cempra Inc. (NASDAQ:CEMP) gained $0.90 (29%) to $4.05 on Friday after Taksta fusidic acid met the primary endpoint of non-inferiority to linezolid in a Phase III trial to treat acute bacterial skin and skin structure infections.

In the trial’s intent-to-treat (ITT) population (n=716), 87.2% of patients treated with oral Taksta achieved an early clinical response vs. 86.6% of patients receiving oral linezolid. The bounds of the 95% confidence interval were 4.6 and 5.9, meeting the 10% non-inferiority margin defined for the primary endpoint. Early clinical response was defined as a ≥20% reduction from baseline in lesion size at 48-72 hours without rescue antibiotic use. Taksta also showed comparable efficacy to linezolid in clinical success rates at the end of 10 days of treatment (91.9% vs. 89.6%) and at the post-treatment evaluation 7-14 days later (88.6% vs. 88.5%)...