Biopharmaceutical firm Tetraphase Pharmaceuticals has closed patient enrolment in the Phase III IGNITE4 clinical trial of eravacycline for the treatment of complicated intra-abdominal infections (cIAI).
Eravacycline is a fully synthetic fluorocycline antibiotic being designed to treat serious infections such as those caused by multidrug-resistant (MDR) pathogens.
The double-blind, double-dummy, randomised, multi-centre, prospective Phase III trial will evaluate the efficacy, safety and pharmacokinetics of twice-daily eravacycline compared to meropenem in 450 adult patients at 75 centres.
Tetraphase president and chief executive officer Guy Macdonald said: “Completing IGNITE4 enrolment ahead of schedule speaks to the strong investigator support for this study, along with the dedication and hard work by our internal team and collaborating clinical research organisation.
"Assuming a positive outcome, we believe the data from IGNITE4, along with data from the successfully completed IGNITE1 trial, will form the basis of a US NDA filing for IV eravacycline in cIAI.”
The trial's primary endpoint is clinical response at the test-of-cure (TOC) visit, using a 12.5% non-inferiority margin.
It is expected that the top-line results from the IGNITE4 trial will be reported in the third quarter of this year.
The firm also intends to submit a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for IV eravacycline, based on the favourable results from the IGNITE1 clinical trial for cIAI.
Eravacycline has undergone evaluation in more than 1,300 patients and in two completed Phase III trials, IGNITE1 in cIAI patients and IGNITE2 in patients with complicated urinary tract infections (cUTI).