Post-hoc analysis of IGNITE1 and IGNITE4 trials of eravacycline met endpoints in complicated intra-abdominal infections.- Tetraphase Pharma.

Tetraphase Pharmaceuticals recently reported data on eravacycline, which is currently under review by the FDA and the EMA for the treatment of complicated intra-abdominal infections (cIAI) at the American Society for Microbiology (ASM) Microbe 2018 Annual Meeting. This is the first post-hoc analysis of IGNITE1 and IGNITE4 – two of the Investigating Gram-Negative Infections Treated with Eravacycline (IGNITE) phase III trials for eravacycline. IGNITE1 and IGNITE4 were randomized, double-blind, double-dummy, multi-center studies assessing the efficacy and safety of intravenous (IV) eravacycline compared to ertapenem and meropenem, respectively, in patients with cIAI. IGNITE1 included 541 patients and used a 10% non-inferiority margin, while IGNITE4 included 500 patients and used a 12.5% non-inferiority margin. Both IGNITE1 and IGNITE4 met the primary endpoints of clinical cure with eravacycline achieving high cure rates in patients with Gram-negative and Gram-positive pathogens, including resistant isolates.

The primary objective of the pooled analysis was to compare the clinical and microbiological responses at the test-of-cure (TOC) visit for subjects in the two treatment groups, with an emphasis on the response of MDR pathogens to eravacycline. For patients with cIAI caused by Enterobacteriaceae, the overall favorable clinical and microbiological response rates among pooled eravacycline-treated subjects were 88.2% and 86.3%, respectively. Notably, in patients with infections due to ESBL-producing Enterobacteriaceae, eravacycline demonstrated a favorable microbiologic response rate of 88.9%. For patients with cIAI caused by A. baumannii, of which most strains were MDR, the overall favorable clinical and microbiological response rate among pooled eravacycline-treated subjects was 100%.