– 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 –
WATERTOWN, MA, USA I September 3, 2013 I Tetraphase Pharmaceuticals, Inc. (TTPH) today announced the dosing of the first patient in its Phase 3 clinical trial of its lead drug candidate eravacycline for the treatment of complicated intra-abdominal infections (cIAI). The cIAI study is the first of two planned Phase 3 clinical trials of eravacycline: one for the treatment of cIAI and one for the treatment of complicated urinary tract infections (cUTI). This first Phase 3 global study of eravacycline is designed to assess the efficacy and safety of eravacycline compared with ertapenem in cIAI.
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,” said Guy Macdonald, Tetraphase President and Chief Executive Officer. “We believe that eravacycline has the potential to serve as an important first-line empiric monotherapy treatment option for patients suffering from cIAI, cUTI, and other difficult-to-treat multi-drug resistant bacterial infections.”
In September 2012 at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, Tetraphase announced positive clinical data from its Phase 2 study of eravacycline for the treatment of cIAI. In the study, eravacycline was highly active against drug-resistant bacterial pathogens, demonstrating infection cure rates similar to that of ertapenem (the comparator drug used in the trial) for the treatment of cIAI and a strong safety profile (with low rates of gastrointestinal side effects).
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:
- Intent-to-treat (ITT)
- Clinically evaluable (CE)
- Micro-ITT (for EOT and FU)
- Microbiologically evaluable (ME)
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.
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 MDR Gram-negative infections.
SOURCE: Tetraphase Pharmaceuticals
Post Views: 155
– 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 –
WATERTOWN, MA, USA I September 3, 2013 I Tetraphase Pharmaceuticals, Inc. (TTPH) today announced the dosing of the first patient in its Phase 3 clinical trial of its lead drug candidate eravacycline for the treatment of complicated intra-abdominal infections (cIAI). The cIAI study is the first of two planned Phase 3 clinical trials of eravacycline: one for the treatment of cIAI and one for the treatment of complicated urinary tract infections (cUTI). This first Phase 3 global study of eravacycline is designed to assess the efficacy and safety of eravacycline compared with ertapenem in cIAI.
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,” said Guy Macdonald, Tetraphase President and Chief Executive Officer. “We believe that eravacycline has the potential to serve as an important first-line empiric monotherapy treatment option for patients suffering from cIAI, cUTI, and other difficult-to-treat multi-drug resistant bacterial infections.”
In September 2012 at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, Tetraphase announced positive clinical data from its Phase 2 study of eravacycline for the treatment of cIAI. In the study, eravacycline was highly active against drug-resistant bacterial pathogens, demonstrating infection cure rates similar to that of ertapenem (the comparator drug used in the trial) for the treatment of cIAI and a strong safety profile (with low rates of gastrointestinal side effects).
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:
- Intent-to-treat (ITT)
- Clinically evaluable (CE)
- Micro-ITT (for EOT and FU)
- Microbiologically evaluable (ME)
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.
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 MDR Gram-negative infections.
SOURCE: Tetraphase Pharmaceuticals
Post Views: 155
