̶ IV Eravacycline Achieves Primary Endpoint in Second of Two Pivotal Trials in cIAI ̶
̶ Company Proceeding with Regulatory Submissions in
̶ Ongoing Phase 3 IGNITE3 Clinical Trial in cUTI Expected to Complete Enrollment Early 4Q 2017 ̶
̶ Conference Call Scheduled for Today at 5:00 p.m. ET ̶
"Complicated intra-abdominal infections are increasingly caused by resistant pathogens and appropriate antibiotic therapy is critical to successful outcomes," commented
Top-line Results from Phase 3 IGNITE4 Clinical Trial in Patients with cIAI: Summary of
A summary of the IGNITE4 efficacy data is outlined in the following table and described below:
|95% Confidence Interval (CI)|
|Microbiological intent-to-treat (micro-ITT) population; 12.5% non-inferiority margin (FDA)||177/195 (90.8%)||187/205 (91.2%)||-6.3, 5.3|
Modified intent-to-treat (MITT);
12.5% non-inferiority margin (EMA)
|231/250 (92.4%)||228/249 (91.6%)||-4.1, 5.8|
Clinically evaluable (CE);
12.5% non-inferiority margin (EMA)
|218/225 (96.9%)||222/231 (96.1%)||-2.9, 4.5|
Eravacycline achieved high clinical cure rates in patients with complicated intra-abdominal infections, comparable to patients in the meropenem group. The primary efficacy analysis under the
There were no treatment-related serious adverse events (SAEs) in the trial. Treatment-emergent adverse event (TEAEs) rates were similar in both treatment groups. The most commonly reported drug-related adverse events (AEs) for eravacycline were infusion site reactions, nausea and vomiting, each occurring at a rate of less than 5%. The AE profile for IV eravacycline in IGNITE4 was consistent with that seen in the previously completed phase 3 IGNITE1 and phase 2 clinical trials in cIAI.
The spectrum of pathogens in this trial was similar to that seen in previously completed clinical trials in this patient population. The most common Gram-negative pathogens in the study included Escherichia coli, Klebsiella pneumonia, Pseudomonas and Bacteroides.
Tetraphase plans to submit a New Drug Application (NDA), which will be supported by data from the IGNITE1 and IGNITE4 clinical trials, to the
"The successful outcome of this second of two pivotal phase 3 trials investigating twice-daily IV eravacycline for the treatment of cIAI is a critical achievement for Tetraphase as we continue preparations to submit our first NDA to the
In parallel with the clinical trials investigating IV eravacycline, Tetraphase is also developing an oral formulation of eravacycline. The Company has completed certain phase 1 clinical studies designed to identify optimal dosing regimen and exposure. Further phase 1 clinical testing is currently ongoing and the company expects to provide an update with top-line findings and potential next steps during the third quarter of 2017.
Conference Call Information
Tetraphase will host a conference call today at
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 intravenous eravacycline (1.0 mg/kg every 12 hours) compared with meropenem (1g every 8 hours) for the treatment of cIAI. The study enrolled 500 adult patients at 66 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 was conducted using a 12.5% non-inferiority margin in the microbiological intent-to-treat (micro-ITT) population.
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 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 previous 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 or at all; whether the results of the Company's development efforts will warrant regulatory submission and whether any such submissions will receive approval from the
Tetraphase Pharmaceuticals Teri Dahlman617-600-7040 email@example.com Argot Partners Maeve Conneighton206.899.4940 firstname.lastname@example.org Media Contact: Sam Brown Inc. Mike Beyer312-961-2502 Mikebeyer@sambrown.com
News Provided by Acquire Media