Tetraphase Pharmaceuticals has announced the dosing of its first patient in IGNITE4, the phase 3 clinical study analysing the efficacy and safety of intravenous (IV) eravacycline compared to meropenem in complicated intra-abdominal infections (cIAI).
Eravacycline is an 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.
Tetraphase president and CEO Guy Macdonald said: “Patient dosing is now underway in IGNITE4, and we continue to expect top-line data in the fourth quarter of 2017.
"If successful, this data, along with data from our positive IGNITE1 study in cIAI, will support a new drug application (NDA) submission for IV eravacycline in cIAI.
“Antibiotic resistance continues to be a growing public health threat and this critical issue is achieving attention on a global scale, most recently as an area of focus at the United Nations General Assembly.
"Tetraphase is committed to being part of the solution by working to develop new antibiotics to treat these serious infections.”
IGNITE4 is a phase 3 randomised, double-blind, double-dummy, multicentre, prospective study designed to determine the efficacy, safety and pharmacokinetics of twice-daily eravacycline (1.0mg/kg every 12 hours) compared with meropenem (1g every eight hours) for the treatment of cIAI.
The trial is expected to see enrolment of around 450 adult patients at 75 centres worldwide.
The primary endpoint of IGNITE4 is a clinical response at the test-of-cure (TOC) visit, which occurs 25 to 31 days after the initial dose of the study drug.
Primary efficacy analysis will be conducted using a 12.5% non-inferiority margin in the microbiological intent-to-treat (micro-ITT) population.