Tetraphase Pharmaceuticals Completes Enrollment in Lead-in Portion of IGNITE 2 Eravacycline Phase 3 Clinical Trial in cUTI
WATERTOWN, Mass.--(BUSINESS WIRE)--June 19, 2014 - Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) announced today that it has completed patient enrollment in the lead-in portion of its IGNITE 2 clinical trial. This two-part Phase 3 clinical trial is studying the safety and efficacy of intravenous (IV) and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI). The lead-in portion of this trial was designed to inform the selection of an oral dose to take forward into the pivotal portion of the Phase 3 trial; Tetraphase anticipates announcing top-line data in the third quarter of this year.
"We are very pleased to have completed enrollment in the lead-in portion of the IGNITE 2 trial," said Guy Macdonald, President and CEO of Tetraphase. "Because of its potential as an IV to oral transition therapy and its potential to be effective against a wide variety of bacterial pathogens, we believe that eravacycline could play an important role in treating complicated urinary tract infections, particularly those caused by multidrug-resistant Gram-negative bacteria."
Tetraphase is developing its lead antibiotic candidate, eravacycline, in its Phase 3 global clinical program IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) as a potent new broad-spectrum antibiotic to treat complicated intra-abdominal infections (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 (CDC) in September 2013.
In addition to IGNITE 2, Tetraphase is actively enrolling patients in IGNITE 1, a Phase 3 clinical trial evaluating the safety and efficacy of IV eravacycline in the treatment of cIAI. The Company expects to complete enrollment in this trial later this year and to announce top-line data in the first quarter of 2015.
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. The trial is a non-inferiority (10% margin) study. The primary endpoint of the trial is clinical response at the test-of-cure (TOC) visit in the microbiological intent-to-treat (micro-ITT) patient population in the two treatment arms. The trial is also comparing the microbiologic response in the treatment arms at the end of treatment and TOC visits in the micro-ITT and microbiologically evaluable populations. The TOC visit takes place 25 to 31 days after the initial dose of eravacycline. The follow-up visit is conducted 38 to 50 days after the initial dose of eravacycline.
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, received 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).
Following completion of 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.
About Tetraphase Pharmaceuticals, Inc.
Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening bacterial infections, 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 (CDC). Tetraphase's lead product candidate, eravacycline, is being developed as a broad-spectrum intravenous and oral antibiotic in the IGNITE program (Investigating Gram-negative Infections Treated with Eravacycline). Under this program, two Phase 3 clinical trials are ongoing: IGNITE 1 for the indication of complicated intra-abdominal infections (cIAI) and IGNITE 2 for complicated urinary tract infections (cUTI). Tetraphase has created more than 3,000 novel tetracycline analogs using its technology platform; in addition to eravacycline, Tetraphase has generated multiple preclinical antibiotic candidates that are currently being evaluated for clinical suitability. Please visit www.tphase.com for more company information.
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 through the end of 2015; 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 and generate results when expected; whether eravacycline will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if eravacycline obtains approval, it will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on May 12, 2014. In addition, the forward-looking statements included in this press release represent our views as of June 19, 2014. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.
Source: Tetraphase Pharmaceuticals
Posted: June 2014