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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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