First patient dosed in IGNITE3 Phase III trial of intravenous (IV) eravacycline compared to ertapenem for urinary tract infections.- Tetraphase Pharma

Tetraphase Pharmaceuticals, Inc.announced dosing of the first patient in IGNITE3 , the Company's phase III clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to ertapenem in complicated urinary tract infections (cUTI).

Eravacycline is a novel antibiotic candidate with potent activity against multidrug-resistant (MDR) pathogens, including carbapenem-resistant Enterobacteriaceae (CRE), Acinetobacter baumannii, and colistin-resistant bacteria carrying the mcr-1 gene, that is being developed for the treatment of serious and life-threatening bacterial infections.

These data are expected to support a supplemental New Drug Application (sNDA) submission for IV eravacycline in cUTI. The company remains on track to report top-line results from the ongoing IGNITE4 study in complicated intra-abdominal infections during the fourth quarter of 2017, followed by an NDA submission for IV eravacycline in cIAI.

IGNITE3 is a randomized, multi-center, double-blind, phase 3 clinical trial evaluating the efficacy and safety of once-daily IV eravacycline (1.5mg/kg every 24 hours) compared to ertapenem (1g every 24 hours) for the treatment of cUTI. IGNITE3 is expected to enroll approximately 1,000 patients who will be randomized 1:1 to receive eravacycline or ertapenem for a minimum of 5 days, and will then be eligible for transition to an approved oral agent. The co-primary endpoints of responder rate (a combination of clinical cure and microbiological success) in the microbiological intent-to-treat (micro-ITT) population at the end-of-IV treatment visit and at the test-of-cure visit (Day 5-10 post therapy) will be evaluated using a 10% non-inferiority margin.