Tetraphase Pharma (TTPH) Announces Dosing of First IGNITE4 Phase 3 Patient

October 14, 2016 7:33 AM EDT
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Tetraphase Pharmaceuticals, Inc. (Nasdaq: TTPH) announced dosing of the first patient in IGNITE4, the Company’s phase 3 clinical trial evaluating the efficacy and safety of intravenous (IV) eravacycline compared to meropenem in complicated intra-abdominal infections (cIAI). Eravacycline is a novel antibiotic candidate with potent activity against multidrug-resistant (MDR) pathogens, including carbapenem-resistant enterobacteriaceae (CRE), Acinetobacter baumannii, and colistin-resistant bacteria carrying the mcr-1 gene, that is being developed for the treatment of serious and life-threatening bacterial infections.

“Patient dosing is now underway in IGNITE4, and we continue to expect top-line data in the fourth quarter of 2017. If successful, these data, along with data from our positive IGNITE1 study in cIAI, will support a new drug application (NDA) submission for IV eravacycline in cIAI,” said Guy Macdonald, President and Chief Executive Officer of Tetraphase. “Antibiotic resistance continues to be a growing public health threat and this critical issue is achieving attention on a global scale, most recently as an area of focus at the United Nations General Assembly. Tetraphase is committed to being part of the solution by working to develop new antibiotics to treat these serious infections.”

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 (1.0 mg/kg every 12 hours) compared with meropenem (1g every 8 hours) for the treatment of cIAI. The study is expected to enroll approximately 450 adult patients at 75 centers worldwide. The primary endpoint of IGNITE4 is clinical response at the test-of-cure (TOC) visit, which occurs 25 to 31 days after the initial dose of the study drug. The primary efficacy analysis will be conducted using a 12.5% non-inferiority margin in the microbiological intent-to-treat (micro-ITT) population.

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