Tetraphase says IGNITE3 trial did not achieve its co-primary endpoints
Tetraphase Pharmaceuticalsannounced that its IGNITE3 clinical trial evaluating the efficacy and safety of once-daily intravenouseravacycline compared to ertapenem for the treatment of patients with complicated urinary tract infections did not achieve statistical non-inferiority of eravacycline to ertapenem. The study failed to meet the co-primary efficacy endpoints of responder rate in the microbiological intent-to-treat (micropopulation at the end-of-IV treatment visit and at the test-of-cure (TOC) visit, which were evaluated using a 10% non-inferiority margin. Eravacycline was well tolerated in IGNITE3, with a safety profile consistent with prior studies. "We are surprised and obviously very disappointed that the IGNITE3 trial did not achieve its co-primary endpoints and are fully analyzing the data to understand this outcome," said Guy Macdonald, President and CEO of Tetraphase. "Independent of this outcome, we continue to move forward with our registration strategy for eravacycline in complicated intra-abdominal infections. We currently have an NDA under review with the FDA as well as an MAA under review by the EMA in Europe, which are based on the positive outcomes demonstrating high cure rates and favorable tolerability in the IGNITE1 and IGNITE4 phase 3 clinical trials of IV eravacycline in cIAI. We are actively preparing for the commercialization of eravacycline as a treatment in cIAI in both the U.S and in Europe, assuming regulatory approvals."