WATERTOWN, MA, USAI March 20, 2014 I Tetraphase Pharmaceuticals, Inc. (TTPH) today provided a clinical update on its lead antibiotic candidate, eravacycline, and its Phase 3 global clinical program IGNITE (Investigating Gram-negative Infections Treated with Eravacycline). Tetraphase is developing eravacycline as a potent new broad-spectrum antibiotic to treat multidrug-resistant (MDR) infections, including those caused by many of the MDR Gram-negative bacteria highlighted as urgent public health threats by the Centers for Disease Control and Prevention (CDC) in September 2013.
The Company announced today that 50% of targeted enrollment has been achieved in IGNITE 1, which it initiated in late August 2013 to investigate the safety and efficacy of eravacycline in the treatment of complicated intra-abdominal infections (cIAI). The company also announced that it has begun patient enrollment in IGNITE 2, the company’s two-part Phase 3 clinical trial studying the safety and efficacy of intravenous (IV) and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI).
Tetraphase continues to expect to have data from the lead-in portion of IGNITE 2 in mid-2014, top-line data from IGNITE 1 in the first quarter of 2015, and top-line data from IGNITE 2 in mid-2015; and to file for U.S. regulatory approval of eravacycline for both indications by the end of 2015.
“The rate of enrollment in IGNITE 1 is encouraging and indicative of strong investigator enthusiasm for eravacycline,” said Guy Macdonald, President and CEO of Tetraphase. “Eravacycline remains the only late-stage antibiotic being developed for intravenous and oral dosing against MDR Gram-negative infections, underscoring its significant potential in both indications being pursued. We believe IV-to-oral step-down use is particularly important in light of the rising incidence of resistance to current standards of care that use the IV-to-oral step-down treatment paradigm. In the near-term, we look forward to the results from the lead-in portion of the IGNITE 2 trial in mid-2014 and to selecting an optimal oral dose to take forward into the pivotal portion of the trial.”
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 1.0 mg/kg every 12 hours, compared with ertapenem, dosed 1 g every 24 hours, in the treatment of cIAI. The study is designed to enroll 536 adult patients 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 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, 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 study 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.
SOURCE: Tetraphase Pharmaceuticals
Post Views: 133
WATERTOWN, MA, USAI March 20, 2014 I Tetraphase Pharmaceuticals, Inc. (TTPH) today provided a clinical update on its lead antibiotic candidate, eravacycline, and its Phase 3 global clinical program IGNITE (Investigating Gram-negative Infections Treated with Eravacycline). Tetraphase is developing eravacycline as a potent new broad-spectrum antibiotic to treat multidrug-resistant (MDR) infections, including those caused by many of the MDR Gram-negative bacteria highlighted as urgent public health threats by the Centers for Disease Control and Prevention (CDC) in September 2013.
The Company announced today that 50% of targeted enrollment has been achieved in IGNITE 1, which it initiated in late August 2013 to investigate the safety and efficacy of eravacycline in the treatment of complicated intra-abdominal infections (cIAI). The company also announced that it has begun patient enrollment in IGNITE 2, the company’s two-part Phase 3 clinical trial studying the safety and efficacy of intravenous (IV) and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI).
Tetraphase continues to expect to have data from the lead-in portion of IGNITE 2 in mid-2014, top-line data from IGNITE 1 in the first quarter of 2015, and top-line data from IGNITE 2 in mid-2015; and to file for U.S. regulatory approval of eravacycline for both indications by the end of 2015.
“The rate of enrollment in IGNITE 1 is encouraging and indicative of strong investigator enthusiasm for eravacycline,” said Guy Macdonald, President and CEO of Tetraphase. “Eravacycline remains the only late-stage antibiotic being developed for intravenous and oral dosing against MDR Gram-negative infections, underscoring its significant potential in both indications being pursued. We believe IV-to-oral step-down use is particularly important in light of the rising incidence of resistance to current standards of care that use the IV-to-oral step-down treatment paradigm. In the near-term, we look forward to the results from the lead-in portion of the IGNITE 2 trial in mid-2014 and to selecting an optimal oral dose to take forward into the pivotal portion of the trial.”
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 1.0 mg/kg every 12 hours, compared with ertapenem, dosed 1 g every 24 hours, in the treatment of cIAI. The study is designed to enroll 536 adult patients 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 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, 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 study 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.
SOURCE: Tetraphase Pharmaceuticals
Post Views: 133
