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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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July 30, 2014
07:34 EDTTTPHFDA and National Institutes of Health hold a workshop
The Development of New Antibacterial Products: Charting a Course for the Future explores key issues and challenges related to antibacterial product development and discusses the development of streamlined regulatory pathways for bringing new antibacterial drugs to market in a meeting being held in North Bethesda, Maryland on July 30-31 at 8 am.
July 29, 2014
07:17 EDTTTPHBMO Capital to hold a conference
3rd Annual Biotech Corporate Access Day to be held in Boston on July 29.
July 28, 2014
08:02 EDTTTPHTetraphase completes enrollment of IGNITE 1 Eravacycline Phase 3 trial
Tetraphase Pharmaceuticals has completed patient enrollment in IGNITE 1, its Phase 3 clinical trial evaluating the safety and efficacy of eravacycline in the treatment of complicated intra-abdominal infections. The Company expects to report top-line results from IGNITE 1 in early first quarter 2015. Tetraphase is developing its lead antibiotic candidate, eravacycline, in a Phase 3 global clinical program IGNITE as a potent new broad-spectrum antibiotic to treat 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 in September 2013. Eravacycline is the only antibiotic in late-stage development for intravenous and oral dosing against MDR Gram-negative infections. Its broad spectrum activity combined with IV and oral dosing may provide an important treatment option for patients with multidrug-resistant bacterial infections. 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. This designation, which is assigned to qualifying new antibiotic product candidates, makes eravacycline eligible to benefit from certain development and commercialization incentives, including priority review, and eligibility for both fast-track status and an additional five years of U.S. market exclusivity.

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