Eravacycline: Additional Phase III data

Additional data from the double-blind, double-dummy, international Phase III IGNITE 1 trial in 541 patients with cIAI showed that 1 mg/kg IV eravacycline every 12 hours led to clinical cure in 86.8% of patients in the microbiological ITT population (n=446) at the TOC visit 25-31 days after the start of treatment -- the FDA-defined primary endpoint -- vs. 87.6% of patients receiving once-daily 1 g IV Invanz ertapenem. Additionally, eravacycline led to clinical cure in 92.9% of patients in the clinically evaluable population (n=477) at the TOC visit -- the EMA-defined primary endpoint -- vs. 94.5% for Invanz. Data were presented at the European Congress of Clinical Microbiology and Infectious Diseases in Copenhagen. Tetraphase previously reported that eravacycline met both the FDA- and EMA-defined primary endpoints of non-inferiority to Invanz in clinical response at the TOC visit (see BioCentury, Dec. 22, 2014). ...