20.03.2014 13:42:09
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Tetraphase Updates On Progress Of Phase 3 Lead Antibiotic Candidate Eravacycline
(RTTNews) - Tetraphase Pharmaceuticals Inc. (TTPH) issued a clinical update on its lead antibiotic candidate, eravacycline, and its Phase 3 global clinical program IGNITE or Investigating Gram-negative Infections Treated with Eravacycline.
The company is developing eravacycline as a potent new broad-spectrum antibiotic to treat multidrug-resistant or MDR 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 or CDC in September 2013.
The company announced 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 or cIAI.
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 (IV) and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI).
The firm said it 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.
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