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 (QIDP); 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 (GAIN Act), which was enacted in
"We are delighted that eravacycline has received Fast Track designation for both formulations and for both therapeutic indications being pursued," said
About IGNITE 1
IGNITE 1 is a randomized, multi-center, double-blind, double-dummy, global Phase 3 clinical trial designed to assess the efficacy and safety of eravacycline, dosed intravenously 1.0 mg/kg every 12 hours, compared with ertapenem, dosed intravenously 1 g every 24 hours, in the treatment of cIAI. The trial is designed to enroll 536 adult patients in approximately 100 centers worldwide and to be a non-inferiority (10% margin) study. The primary endpoint is clinical response at the test-of-cure visit in the microbiological intent-to-treat (micro-ITT) patient population.
About IGNITE 2
IGNITE 2 is a two-part, randomized, multi-center, double-blind, Phase 3 clinical trial designed to assess the efficacy and safety of eravacycline compared with levofloxacin in the treatment of cUTI at approximately 150 clinical trial sites worldwide. The two-part trial features a lead-in portion, in which approximately 120 patients, randomized 1:1:1, will receive eravacycline in one of two IV-to-oral step down dosing cohorts (1.5 mg/kg intravenously every 24 hours followed by 200 mg or 250 mg orally every 12 hours) or levofloxacin (750 mg intravenously every 24 hours followed by 750 mg orally every 24 hours).
Under the planned trial protocol, following treatment of the 120 patients in the lead-in portion of the trial, an evaluation of primary efficacy, safety, and tolerability endpoints will be conducted in a planned interim analysis to determine the dose regimen to be carried forward into the second portion of the trial. An additional 720 patients are expected to then be enrolled and randomized 1:1 to receive the selected dose regimen of eravacycline or levofloxacin. This 720-patient trial is designed to be a non-inferiority (10% margin) study with a primary endpoint of clinical and microbiological response approximately seven days after completion of treatment.
Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening multidrug-resistant (MDR) bacterial infections, including many of the MDR Gram-negative bacteria highlighted as urgent public health threats by the
Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "anticipates," "believes," "expects," "plans," "will" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including:whether our cash resources will be sufficient to fund our continuing operations into the first quarter of 2016; whether results obtained in preclinical studies and early clinical trials will be indicative of results obtained in future clinical trials; whether eravacycline will advance through the clinical trial process on a timely basis or at all; whether enrollment for clinical trials will be achieved in the time frame expected; whether submissions will made and approvals will be received from the