US-based Tetraphase Pharmaceuticals (TTPH) has started patient enrolment in the pivotal portion of its IGNITE 2 Phase III two-part trial evaluating the efficacy and safety of intravenous (IV) and oral formulations of eravacycline to treat complicated urinary tract infections (cUTI).
The company has selected the 200mg eravacycline oral dose for the pivotal portion of the trial after assessing the positive results from the lead-in portion of the trial.
In the lead-in portion of the trial, the IV-to-oral dosing regimen of eravacycline 1.5mg/kg IV followed by 200mg oral dose showed favourable results compared to levofloxacin, the comparator drug in the trial.
The responder outcomes (FDA endpoint) for the IV-to-oral 200mg and levofloxacin groups were 70.8% and 52.2%, respectively, while the microbiological responses (EMA endpoint) were 75% and 56.5%, respectively.
The company said that overall, treatment was generally well tolerated in all groups, and the pharmacokinetics of the IV-to-oral 200mg dose of eravacycline were comparable to the IV formulation.
Full data from the lead-in portion of the IGNITE 2 Phase III trial will be reported by the company at an upcoming scientific meeting.
Tetraphase president and CEO Guy Macdonald said: "Initiation of the pivotal portion of the IGNITE 2 trial is an important milestone and we look forward to top-line data from the study in mid-2015.
"We believe eravacycline is a differentiated antibiotic candidate given its potential as an IV-to-oral transition therapy and its activity against a wide variety of bacterial pathogens, including multidrug-resistant Gram-negative bacteria.
"IGNITE 2 is the second study in our IGNITE pivotal program, which also includes IGNITE 1, a Phase 3 clinical trial of an IV formulation of eravacycline in complicated intra-abdominal infections.
"We expect to announce top-line data from IGNITE 1 early in the first quarter of 2015."
The two-part, randomised, multi-centre, double-blind, IGNITE 2 Phase III trial will be conducted at about 150 clinical trial sites across the world.