"The incidence of life-threatening infections caused by drug-resistant bacteria is increasing at alarming rates. Without the introduction of new antibiotics, a clear public health threat is evolving," said
"The positive results from IGNITE1 demonstrate that treatment with eravacycline could fill an unmet need in patients
with cIAI, particularly those with difficult-to-treat infections," said
IGNITE1 was 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 mg/kg every 12 hours, compared with ertapenem, dosed intravenously 1 g every 24 hours, for four up to 14 days. Per the trial design, 541 adult patients were enrolled in the trial at 66 centers worldwide. Under the guidance set by the
In the IGNITE1 study, in the micro-ITT population, the lower and upper bounds of the 95% confidence interval were -7.1% and 5.5%, respectively. In the MITT and CE populations, the lower and upper bounds of the 99% confidence interval were -9.2% and 5.6%; and -7.9% and 4.4%, respectively. Eravacycline demonstrated high clinical cure rates against Gram-negative pathogens, including those that were carbapenem-resistant, 3rd/4th generation cephalosporin-resistant, or multidrug-resistant.
IGNITE4 is a phase 3 randomized, double-blind, double-dummy, multicenter, prospective study that is designed to assess the efficacy, safety and pharmacokinetics of twice-daily eravacycline (1 mg/kg every 12 hours) compared with meropenem (1 g every 8 hours) for the treatment of cIAI. The study is expected to enroll approximately 450 adult patients at 75 centers worldwide. Per agreement with the
Eravacycline is a novel, fully-synthetic tetracycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens that have been highlighted as urgent public health threats by both the
Eravacycline is currently being investigated in the Company's phase 3 IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) program. To date, eravacycline has been tested in over 1,300 patients and has been tested in two completed phase 3 trials - IGNITE1 in patients with cIAI and IGNITE2 in patients with cUTI. In IGNITE1, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem, was well tolerated, and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. Tetraphase is currently evaluating eravacycline in a second phase 3 clinical trial in patients with cIAI (IGNITE4) comparing twice-daily IV eravacycline to meropenem. Assuming a positive outcome in IGNITE4, the Company plans to use the results from IGNITE1 and IGNITE4 to support an NDA submission for IV eravacycline for the treatment of patients with cIAI. The Company plans to initiate IGNITE3, an additional phase 3 trial evaluating once-daily IV eravacycline in patients with cUTI. Assuming a positive outcome, the Company plans to use the results from IGNITE3 to support a supplemental NDA (sNDA) submission for eravacycline in cUTI. In parallel, Tetraphase is continuing its efforts to develop an oral dose formulation of eravacycline. A phase 1 clinical program is ongoing which is designed to evaluate and optimize the oral dosing regimen for eravacycline.
Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening bacterial infections, including those caused by many of the multidrug-resistant (MDR) bacteria highlighted as urgent public health threats by the
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 results obtained in early or interim clinical trials will be indicative of results obtained in future clinical trials; whether eravacycline or any other clinical candidate will advance through the clinical trial process on a timely basis; whether the results of the Company's trials will warrant regulatory submission and regulatory approval from the
Tetraphase Pharmaceuticals Teri Dahlman617-600-7040 firstname.lastname@example.org Argot Partners Maeve Conneighton212-600-1902 email@example.com Media Contact: Sam Brown Inc. Mike Beyer312-961-2502 firstname.lastname@example.org
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