19.06.2014 14:08:52
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Tetraphase Closes Patient Enrollment In Lead-in Portion Of IGNITE 2 Trial
(RTTNews) - Tetraphase Pharmaceuticals Inc. (TTPH) announced Thursday that it has completed patient enrollment in the lead-in portion of its IGNITE 2 clinical trial. This two-part Phase 3 clinical trial is studying the safety and efficacy of intravenous (IV) and oral formulations of eravacycline for the treatment of complicated urinary tract infections or cUTI.
The lead-in portion of this trial was designed to inform the selection of an oral dose to take forward into the pivotal portion of the Phase 3 trial. Tetraphase anticipates announcing top-line data in the third quarter of this year.
Tetraphase noted that it is developing its lead antibiotic candidate, eravacycline, in its Phase 3 global clinical program IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) as a potent new broad-spectrum antibiotic to treat complicated intra-abdominal infections (cIAI) and cUTI, including those caused by many of the multidrug-resistant Gram-negative bacteria highlighted as urgent public health threats by the Centers for Disease Control and Prevention (CDC) in September 2013.
In addition to IGNITE 2, Tetraphase is actively enrolling patients in IGNITE 1, a Phase 3 clinical trial evaluating the safety and efficacy of IV eravacycline in the treatment of cIAI. The Company expects to complete enrollment in this trial later this year and to announce top-line data in the first quarter of 2015.
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