Tetraphase Pharmaceuticals Completes Enrollment of IGNITE 1 Eravacycline Phase 3 Clinical Trial
WATERTOWN, Mass.--(BUSINESS WIRE) July 28, 2014 -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) announced today that it 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 (cIAI). The Company expects to report top-line results from IGNITE 1 in early first quarter 2015.
"Strong investigator support for IGNITE 1 from approximately 100 centers worldwide has allowed us to complete enrollment in this trial in just 11 months - well ahead of schedule," said Guy Macdonald, President and CEO of Tetraphase. "This is an exciting and strong start to the second half of 2014 and is the first in a series of IGNITE milestones we expect over the next 18 months. We expect to report later this quarter results from the lead-in portion of the IGNITE 2 trial, our Phase 3 clinical trial evaluating the safety and efficacy of eravacycline in the treatment of complicated urinary tract infections (cUTI), which we conducted to inform selection of the oral dose to take forward into the pivotal portion of the Phase 3 cUTI trial. We then expect top-line data from IGNITE 1 in early first quarter of 2015 and top-line data from IGNITE 2 in mid-2015, and, subject to the results and timing of these trials, are targeting a submission for U.S. regulatory approval of eravacycline for both cIAI and cUTI indications by the end of 2015."
Tetraphase is developing its lead antibiotic candidate, eravacycline, in a Phase 3 global clinical program IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) as a potent new broad-spectrum antibiotic to treat cIAI (IGNITE 1) and cUTI (IGNITE 2), 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. 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 (QIDP) 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.
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. Per the trial design, 536 adult patients were enrolled in the trial in approximately 100 centers worldwide. The primary endpoint of the study 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 study 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 trial protocol also provides for a follow-up visit 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, 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). Tetraphase determined the two eravacycline oral dosing regimens based on its completed Phase 1 oral pharmacokinetic (PK) trial that indicated acceptable plasma drug levels and tolerability in healthy subjects at the 200 mg and 250 mg twice-daily dose levels.
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 study. 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 multidrug-resistant (MDR) bacterial infections, including many of the MDR 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). 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.
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 United States Food and Drug Administration or equivalent foreign regulatory agencies on a timely basis or at all; 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 July 28, 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: July 2014