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Tetraphase Pharmaceuticals Reports First Quarter 2017 Financial Results and Reviews Recent Highlights
WATERTOWN, Mass., May 4, 2017 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical-stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today reported financial results for the first quarter ended March 31, 2017 and provided an overview of recent achievements.
We have continued to make significant advancements across all of our development programs, particularly for IV eravacycline with the early completion of enrollment of IGNITE4 in complicated intra-abdominal infections (cIAI), and the initiation of IGNITE3 in complicated urinary tract infections (cUTI), for which enrollment is progressing well, said Guy Macdonald, President and Chief Executive Officer of Tetraphase. Preparations are ongoing for the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the treatment of cIAI in the third quarter of this year and we look forward to top-line data from IGNITE4 also in the third quarter, which would support a subsequent U.S. New Drug Application (NDA) filing.
Mr. Macdonald added, We also look forward to data from the ongoing phase 1 clinical trials for oral eravacycline which are designed to optimize the oral dosing regimen, and we continue to anticipate providing an update on that program during the third quarter of 2017.
First Quarter and Recent Highlights
|||Completed enrollment for the phase 3 IGNITE4 clinical trial of IV eravacycline in patients with cIAI. IGNITE4 is designed to evaluate IV eravacycline compared to meropenem and is expected to enroll approximately 450 patients. The primary analysis will be conducted using a 12.5% non-inferiority margin. Tetraphase expects to report top-line results in the third quarter of 2017. Assuming a successful outcome, this study, along with data from IGNITE1, would support an NDA filing for IV eravacycline for cIAI.|
|||Initiated the phase 3 IGNITE3 clinical trial of IV eravacycline in patients with cUTI. IGNITE3 is designed to evaluate IV eravacycline compared to ertapenem and is expected to enroll approximately 1,000 patients. The primary analysis will be conducted using a 10% non-inferiority margin. Assuming a positive outcome, the IGNITE3 clinical data are expected to support a supplemental NDA (sNDA) submission for IV eravacycline in cUTI.|
Presented data at ECCMID 2017, including in vitro data for eravacycline demonstrating potent activity against drug-resistant bacteria, specifically Gram-negative bacteria Acinetobacter baumannii and Enterobacteriaceae, including carbapenem-resistant or extended beta-lactamase producing phenotypes, as well as Gram-positive bacteria Staphylococcus aureus and enterococci, including
The following information was filed by Tetraphase Pharmaceuticals Inc (TTPH) on Friday, May 5, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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