WATERTOWN, Mass.--(BUSINESS WIRE)--
Tetraphase Pharmaceuticals, Inc. (TTPH), today announced the design of its planned Phase 3 IV/oral clinical trial of the Company’s lead antibiotic candidate eravacycline in the treatment of complicated urinary tract infections (cUTI). When initiated, this trial will be the second Phase 3 study of eravacycline underway. Tetraphase enrolled the first patient in a Phase 3 trial of eravacycline IV in complicated intra-abdominal infections (cIAI) in late August.
“Eravacycline is the only late-stage antibiotic that is being developed to be dosed intravenously and orally, and that offers broad-spectrum activity, including coverage of carbapenem-resistant bacteria such as E. coli and Klebsiella spp.,” said Guy Macdonald, Tetraphase President and Chief Executive Officer. “As outlined in a recent report from the Centers for Disease Control and Prevention, multi-drug resistant infections, particularly Gram-negative infections, are a serious and rapidly growing threat to public health. With the start of this study, Tetraphase will be evaluating eravacycline in a Phase 3 program in each of two indications, cIAI and cUTI, taking full advantage of an FDA regulatory pathway designed to improve the availability of therapies addressing these serious infections.”
A Two-Part, Randomized, Multi-center, Double-blind Phase 3 Study of Eravacycline in cUTI
The planned randomized, multi-center, double-blind Phase 3 study is designed to assess the efficacy and safety of eravacycline compared with levofloxacin in the treatment of cUTI. 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 (750mg intravenously every 24 hours followed by 750 mg orally every 24 hours). The eravacycline oral dosing regimens were determined based on the Company’s completed Phase 1 oral PK studies, which demonstrated acceptable plasma drug levels and tolerability in healthy subjects at the 200 mg (n=6) and 250 mg (n=6) q12h dose levels.
Under the planned study protocol for the study, following treatment of 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 will then be enrolled and randomized 1:1 to receive the selected dose regimen of eravacycline or levofloxacin.
This 720-patient study will be a non-inferiority (10% margin) study that is powered at 80%; the primary endpoint will be clinical and microbiological response approximately seven days after completion of treatment. The Company recently met with U.S. and European regulators to discuss the proposed study design and expects to initiate enrollment towards the end of 2013.
With regard to the study’s design, Patrick Horn, M.D., Ph.D., Tetraphase Chief Medical Officer, noted: “Our recently completed Phase 1 study of oral eravacycline identified two oral doses with appropriate exposure and tolerability in healthy subjects. As we have not yet examined the IV/oral dosing of eravacycline in patients, this two-stage trial design gives us an opportunity to optimize the dosing regimen for the IV to oral step down prior to initiating the remainder of the Phase 3 study.”
In addition to the planned Phase 3 study in cUTI, the Company recently announced the initiation of a Phase 3 clinical trial of eravacycline IV for the treatment of cIAI. This study of eravacycline is designed to assess the efficacy and safety of eravacycline compared with ertapenem in cIAI. The study is designed to enroll 536 adult patients in approximately 100 centers worldwide. The primary endpoint 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.
Conference Call Information
Tetraphase will host a conference call today at 5:00 pm Eastern Time. The call can be accessed by dialing (877) 312-5517 (U.S. and Canada) or (760) 666-3772 (international). To access the live audio webcast, or the subsequent archived recording, visit the "Investors Relations – Events & Presentations" section of the Tetraphase website at www.tphase.com. The webcast will be recorded and available for replay on the Tetraphase website for 30 days following the call.
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 multi-drug resistant infections. Tetraphase's lead product candidate, eravacycline, is a fully synthetic tetracycline derivative being developed as a broad-spectrum intravenous and oral antibiotic for use as a first-line empiric monotherapy for the treatment of multi-drug resistant infections, including multi-drug resistant Gram-negative infections.
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 "believes," "anticipates," "plans," "expects," 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 for the period anticipated; whether results obtained in preclinical studies and early clinical trials, including the results of our oral Phase 1 studies, will be indicative of results obtained in future clinical trials; whether the planned Phase 3 trial for cUTI will proceed on the basis of the protocol discussed in this release; whether eravacycline will advance into clinical trials and through the clinical trial process on a timely basis and receive approval from the FDA 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 quarterly report on Form 10-Q for the quarter ended June 30, 2013. The forward-looking statements included in this press release represent our views as of September 30, 2013. 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.
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