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April 2, 2014
08:34 EDTTTPHTetraphase awarded Fast Track status by FDA for IV, oral eravacycline
Tetraphase Pharmaceuticals announced that the U.S. Food & Drug Administration has granted Fast Track designations for both the intravenous and oral formulations of the company’s lead antibiotic candidate, eravacycline. Tetraphase is investigating the safety and efficacy of eravacycline in its ongoing Phase 3 global clinical program; the IGNITE 1 study is evaluating the IV formulation of eravacycline for the treatment of complicated intra-abdominal infections; IGNITE 2 is evaluating eravacycline IV-to-oral step-down therapy for the treatment of complicated urinary tract infections. Fast Track designation is awarded to expedite the study and regulatory review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Eravacycline became eligible for Fast Track status as a result of being designated a Qualified Infectious Disease Product; the QIDP designation also makes eravacycline eligible for priority review and an additional five years of U.S. market exclusivity, if approved. These incentives are part of the Generating Antibiotic Incentives Now Act, which was enacted in July 2012 as part of the FDA Safety and Innovation Act and was part of the fifth authorization of the Prescription Drug User Fee Act.
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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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