- First of Two Planned Phase 3 Clinical Trials of Tetraphase's Lead Antibiotic Candidate Designed to Support Submission for Approval in Two Indications: Complicated Intra-abdominal Infections and Complicated Urinary Tract Infections -
Tetraphase is developing eravacycline, a fully synthetic, potent new broad-spectrum, intravenous and oral antibiotic, for use as a first-line monotherapy for the treatment of MDR infections, including MDR Gram-negative pathogens.
"Dosing the first patient in our Phase 3 study for complicated
intra-abdominal infections is an important milestone for Tetraphase,"
About the Phase 3 Study of Eravacycline in cIAI
This Phase 3 randomized, double-blind, double-dummy, multicenter, prospective study is designed to assess the efficacy, safety and pharmacokinetics (PK) of eravacycline (1.0 mg/kg every 12 hours [q12h]) compared with ertapenem (1 g q24h) in the treatment of 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. The study is also designed to evaluate as secondary endpoints the clinical response for patients in the two treatment arms at the end-of-treatment (EOT), TOC, and follow-up (FU) visits in the following populations:
The study will also compare the microbiologic response in the treatment arms at the EOT and TOC visits in the micro-ITT and ME populations. In addition, the study will assess the safety and tolerability of the administration of eravacycline in the safety population and explore PK parameters after eravacycline infusion. Patients will remain on eravacycline treatment until symptoms of cIAI have resolved, but eravacycline will not be given for more than 14 24-hour dosing cycles. The TOC visit will be 25 to 31 days after the initial dose of eravacycline. The follow-up visit will be conducted 38 to 50 days after the initial dose of eravacycline. Comparator drug ertapenem will be used in accordance with its most recent prescribing information.
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 MDR 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, such as the
results referred to in this press release, will be indicative of results
obtained in future clinical trials; whether we are able to develop an
oral formulation of eravacycline on a timely basis or at all; whether
eravacycline will advance into clinical trials and through the clinical
trial process on a timely basis and receive approval from the
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