Tetraphase Announces Top-Line Results from IGNITE3 Phase 3 Clinical Trial of Eravacycline in Complicated Urinary Tract Infections (cUTI)

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WATERTOWN, Mass., Feb. 13, 2018 (GLOBE NEWSWIRE) -- (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that its IGNITE3 clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to ertapenem for the treatment of patients with complicated urinary tract infections (cUTI) did not achieve statistical non-inferiority of eravacycline to ertapenem. The study failed to meet the co-primary efficacy endpoints of responder rate (a combination of clinical cure and microbiological success) in the microbiological intent-to-treat (micro-ITT) population at the end-of-IV (EOI) treatment visit and at the test-of-cure (TOC) visit, which were evaluated using a 10% non-inferiority margin.  Eravacycline was well tolerated in IGNITE3, with a safety profile consistent with prior studies.

“We are surprised and obviously very disappointed that the IGNITE3 trial did not achieve its co-primary endpoints and are fully analyzing the data to understand this outcome,” said Guy Macdonald, President and CEO of Tetraphase. “Independent of this outcome, we continue to move forward with our registration strategy for eravacycline in complicated intra-abdominal infections (cIAI).  We currently have an NDA under review with the FDA as well as an MAA under review by the EMA in Europe, which are based on the positive outcomes demonstrating high cure rates and favorable tolerability in the IGNITE1 and IGNITE4 phase 3 clinical trials of IV eravacycline in cIAI. We are actively preparing for the commercialization of eravacycline as a treatment in cIAI in both the U.S and in Europe, assuming regulatory approvals.”

Mr. Macdonald continued: “There is a clear unmet need for patients with serious infections, particularly those caused by difficult-to-treat Gram-negative bacteria, and we continue to believe that eravacycline can benefit those patients and we are excited to be getting closer to delivering that potential to patients in need."

The phase 3 IGNITE3 clinical trial enrolled 1,205 patients who were randomized 1:1 to receive IV eravacycline (1.5mg/kg every 24 hours) or ertapenem (1g every 24 hours) for a minimum of 5 days, and then were eligible for transition to an appropriate approved oral agent. The co-primary endpoints of responder rate (a combination of clinical cure and microbiological success) in the microbiological intent-to-treat (micro-ITT) population at the EOI visit and at the TOC visit (Day 5-10 post therapy) were evaluated using a 10% non-inferiority margin. Responder rates in the micro-ITT population at the EOI visit were 84.8% and 94.8% for eravacycline (n=363/428) and ertapenem (n=382/403), respectively (-10% CI: -14.1%, -6.0%).  Responder rates at the TOC visit were 68.5% and 74.9% for eravacycline (n=293/428) and ertapenem (n=302/403), respectively (-6.5% CI: -12.6%, -0.3%). 

Eravacycline was investigated in the Company's IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) phase 3 programs. To date, eravacycline has been administered to over 2,700 patients and in two completed phase 3 trials in cIAI, and two completed phase 3 trials in cUTI. In IGNITE1, a pivotal phase 3 trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem, was well tolerated, and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. The IGNITE1 data is serving as the basis of the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of patients with cIAI now under review by the European Medicines Agency (EMA). In IGNITE4, a second phase 3 clinical trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem, was well tolerated, and achieved high cure rates. The Company has used the results from IGNITE1 and IGNITE4 to support a New Drug Application (NDA) submission for IV eravacycline in cIAI. In IGNITE3, once-daily IV eravacycline did not achieve co-primary endpoints and did not achieve statistical non-inferiority of clinical response compared to ertapenem. In IGNITE2, the primary endpoint was also not met.

More news and information about Tetraphase Pharmaceuticals, Inc.

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Globe Newswire: 21:01 GMT Tuesday 13th February 2018

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