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March 20, 2014
08:34 EDTTTPHTetraphase provides update on clinical progress of eravacycline
Tetraphase Pharmaceuticals provided a clinical update on its lead antibiotic candidate, eravacycline, and its Phase 3 global clinical program IGNITE. Tetraphase is developing eravacycline as a potent new broad-spectrum antibiotic to treat multidrug-resistant infections, including those caused by many of the MDR Gram-negative bacteria highlighted as urgent public health threats by the Centers for Disease Control and Prevention in September 2013. The company announced today that 50% of targeted enrollment has been achieved in IGNITE 1, which it initiated in late August 2013 to investigate the safety and efficacy of eravacycline in the treatment of complicated intra-abdominal infections. The company also announced that it has begun patient enrollment in IGNITE 2, the company’s two-part Phase 3 clinical trial studying the safety and efficacy of intravenous and oral formulations of eravacycline for the treatment of complicated urinary tract infections. Tetraphase continues to expect to have data from the lead-in portion of IGNITE 2 in mid-2014, top-line data from IGNITE 1 in the first quarter of 2015, and top-line data from IGNITE 2 in mid-2015; and to file for U.S. regulatory approval of eravacycline for both indications by the end of 2015. Eravacycline has been designated by the U.S. Food and Drug Administration as a Qualified Infectious Disease Product for both the cIAI and cUTI indications.
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