WATERTOWN, Mass.--(BUSINESS WIRE)--Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) today announced initiation of patient enrollment in the pivotal portion of its IGNITE 2 Phase 3 clinical trial, a two-part trial studying the efficacy and safety of intravenous (IV) and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI). The company has selected the 200 mg eravacycline oral dose for the pivotal portion of the study after evaluating the positive results from the lead-in portion of the trial.
As previously reported, in the lead-in portion of the trial, the IV-to-oral dosing regimen of eravacycline (1.5 mg/kg IV followed by 200 mg oral dose) compared favorably to levofloxacin, the comparator drug in the trial. The responder outcomes (FDA endpoint) for the IV-to-oral 200 mg and levofloxacin groups were 70.8% and 52.2%, respectively. The microbiological responses (EMA endpoint) were 75.0% and 56.5%, respectively. Overall, treatment was generally well tolerated in all groups, and the pharmacokinetics of the IV-to-oral 200 mg dose of eravacycline were comparable to the IV formulation. Tetraphase plans to present the full data from the lead-in portion of the IGNITE 2 Phase 3 trial at an upcoming scientific meeting.
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