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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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April 27, 2015
07:08 EDTTTPHTetraphase presents results from phase 3 trials of eravacycline in cIAI, cUTI
Tetraphase Pharmaceuticals announced the first detailed results from phase 3 clinical trials of its lead drug candidate, eravacycline, in development to treat complicated intra-abdominal infections, or cIAI, and complicated urinary tract infections, or cUTI. These results are being presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases, taking place on April 25-28 in Copenhagen, Denmark. "The detailed clinical data presented this year at ECCMID continues to support eravacycline's potential as a potent antibiotic option to treat both cIAI and cUTI infections," said Guy Macdonald, President and CEO of Tetraphase. "We believe that eravacycline will offer physicians additional options when treating bacterial infections given its activity against a wide variety of bacterial pathogens, including multidrug-resistant Gram-negative bacteria, and, in cUTI, its potential as an IV-to-oral transition therapy. We are encouraged by the results achieved in both IGNITE1 and the lead-in portion of IGNITE2 and we look forward to reporting top-line results from the pivotal portion of IGNITE2 in mid-2015." In IGNITE1, eravacycline met the primary endpoint of statistical non-inferiority of clinical response at the test-of-cure visit. The primary analysis under the U.S. Food and Drug Administration guidance was conducted using a 10% non-inferiority margin in the microbiological intent-to-treat population. Under the European Medicines Agency guidance, the primary analysis was conducted using a 12.5% non-inferiority margin of the clinically evaluable patient population. In the lead-in portion of IGNITE2, both IV-to-oral dosing regimens of eravacycline (1.5 mg/kg IV followed by 200 mg or 250 mg) compared favorably to levofloxacin for the treatment of cUTI, supporting the advancement of the trial into its pivotal portion. Efficacy outcomes were microbiological success and responder rates in all randomized subjects with a baseline pathogen identified and the microbiologically evaluable population at a post-treatment visit 7 days after the last dose of study drug. Patient demographics were well matched across all treatment groups.

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