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Tetraphase Announces Positive Top-Line Results from Phase 3 IGNITE4 Clinical Trial in Complicated Intra-Abdominal Infections

̶ Company Proceeding with Regulatory Submissions in Europe in 3Q 2017 and U.S. in 1Q 2018 ̶

̶ 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 ̶

WATERTOWN, Mass., July 25, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced positive top-line results from IGNITE4, the Company's phase 3 clinical trial evaluating the efficacy and safety of twice-daily intravenous (IV) eravacycline compared to meropenem for the treatment of patients with complicated intra-abdominal infections (cIAI). The results of IGNITE4, which enrolled 500 patients, demonstrated statistical non-inferiority of eravacycline to meropenem for the primary efficacy endpoint of clinical response at the test-of-cure (TOC) visit.

“Complicated intra-abdominal infections are increasingly caused by resistant pathogens and appropriate antibiotic therapy is critical to successful outcomes,” commented Joseph Solomkin, M.D., Professor Emeritus in the Department of Surgery at the University of Cincinnati College of Medicine and advisor to the Company. “Collectively, the data from the IGNITE program in cIAI versus two widely-used comparators, ertapenem and meropenem, provides compelling evidence for IV eravacycline monotherapy and its potential to be a valuable new addition to the limited toolkit currently available to treat serious, and often life-threatening MDR infections.”

Top-line Results from Phase 3 IGNITE4 Clinical Trial in Patients with cIAI: Summary of FDA and EMA Primary Efficacy Endpoints
A summary of the IGNITE4 efficacy data is outlined in the following table and described below:

Eravacycline
n/N (%)
Meropenem
n/N (%)
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 U.S. Food and Drug Administration (FDA) guidance was conducted using a 12.5% non-inferiority margin in the micro-ITT population. Clinical cure rates in the micro-ITT population were 90.8% and 91.2% for eravacycline (n=195) and meropenem (n=205), respectively (95% CI: -6.3%,5.3%). Under the EMA guidance, the primary analysis was conducted using a 12.5% non-inferiority margin of the modified intent-to-treat (MITT) and clinically evaluable (CE) patient populations. Clinical cure rates in the MITT population were 92.4% and 91.6% for...


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