Tetraphase's eravacycline antibiotic meets in Phase III for cIAIs

Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH) reported top-line data from the double-blind, international Phase III IGNITE4 trial in 500 patients with complicated intra-abdominal infections (cIAIs) showing that twice-daily 1 mg/kg IV eravacycline (TP-434) met the FDA-defined primary endpoint of non-inferiority to meropenem in clinical response at the test-of-cure (TOC) visit 25-31 days after first dose in the microbiological intent-to-treat (ITT) population (90.8% vs. 91.2%). The non-inferiority margin was 12.5%.

Eravacycline also met the EMA-defined co-primary endpoints of non-inferiority to meropenem in clinical response at the TOC visit in the modified ITT (mITT) (92.4% vs. 91.6%) and clinically evaluable (CE) (96.9% vs. 96.1%) populations...