Tetraphase Pharma (TTPH) Announces Publication of IGNITE1 Data; Statistical non-Inferiority Demonstrated
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Tetraphase Pharmaceuticals, Inc. (Nasdaq: TTPH) announced the publication of results from IGNITE1, the Company’s phase 3 clinical trial which evaluated eravacycline compared to ertapenem for the treatment of complicated intra-abdominal infection (cIAI), in the Journal of the American Medical Association (JAMA) Surgery. The article, titled “IGNITE1: A Phase III, Randomized Multicenter Prospective Study to Assess the Efficacy and Safety of Eravacycline vs. Ertapenem in Complicated Intra-Abdominal Infections,” is available online and will appear in a forthcoming print issue of the journal. In the trial, eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure (TOC) visit, under the guidance set by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
“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 Joseph Solomkin, M.D., Professor Emeritus in the Department of Surgery at the University of Cincinnati College of Medicine, and lead author of the JAMA paper. “These published data demonstrate eravacycline’s ability to cure these infections as a monotherapy because of its activity against Gram-positive, Gram negative and anaerobic bacteria, including those resistant to commonly used antibiotics. These data support its potential as a novel antibiotic treatment option for serious intra-abdominal infections.”
“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 Guy Macdonald, President and CEO of Tetraphase. “These results, along with those from our ongoing phase 3 IGNITE4 trial in cIAI, which are expected in the fourth quarter of 2017, will form the basis of a New Drug Application submission for eravacycline in cIAI.”
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 FDA and the EMA, the primary endpoint of the trial was clinical response at TOC visit, which took place 25 to 31 days after the initial study drug dose, in the two treatment arms. For the FDA, the primary analysis was conducted using a 10% non-inferiority margin in the microbiological intent-to-treat (micro-ITT) population. For the EMA, the primary analysis was conducted using a 12.5% non-inferiority margin in the all-treated (MITT) and clinically evaluable (CE) patient populations.
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 FDA and EMA, the primary endpoint of IGNITE4 is clinical response at the TOC visit, which will be analyzed using a 12.5% non-inferiority margin. The primary analysis populations will be the micro-ITT population for the FDA and the MITT and CE populations for the EMA.
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