Tetraphase announced positive results from the lead-in portion of its IGNITE 2 clinical trial with IV and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI).
IGNITE 2 is a two-part Phase 3 clinical trial studying the efficacy and safety of eravacycline compared with levofloxacin for the treatment of cUTI. The two-part trial consists of a lead-in portion, in which approximately 120 patients, randomized 1:1:1, received eravacycline in one of two IV-to-oral switch dosing cohorts or levofloxacin. The two oral eravacycline dosing regimens was based on a completed Phase 1 oral pharmacokinetic trial that indicated acceptable plasma drug levels and tolerability in healthy subjects at the 200mg and 250mg twice-daily dose levels.
Following treatment in the lead-in portion of the trial, an evaluation of primary efficacy, safety, and tolerability endpoints was to be conducted in a planned interim analysis to determine the dose regimen to be used in the second portion of the trial. An additional 720 patients are expected to be randomized 1:1 to receive the selected dose regimen of eravacycline or levofloxacin. This 720-patient portion of the trial is designed to be a non-inferiority (10% margin) study. The primary endpoint is the responder outcome (a combination of clinical cure rate and microbiological response) in the Microbiological Intent-to-Treat (micro-ITT) Population at the Post-Treatment visit (defined as 6-8 days after the completion of therapy).
Data from the lead-in portion demonstrated that both IV-to-oral dosing regimens of eravacycline compared favorably to levofloxicin. The responder outcome for the IV-to-oral 200mg, IV-to-oral 250mg and levofloxacin groups were 70.8%, 64.3% and 52.2%, respectively. The pharmacokinetics of both oral doses of eravacycline were comparable to the IV formulation.
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