Tetraphase Announces Positive Top-line Results from Phase 3 IGNITE 1 Clinical Trial of Eravacycline in Complicated Intra-abdominal Infections

New antibiotic shown to be effective in treating intra abdominal infections

/ Author:  / Reviewed by: Robert Carlson, M.D Beth Bolt, RPh

Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced positive top-line results from IGNITE 1, the Company's Phase 3 clinical trial of eravacycline for the treatment of complicated intra-abdominal infection (cIAI) compared to ertapenem.

 In the trial, eravacycline met the primary endpoint of statistical non-inferiority of clinical response at the test-of-cure (TOC) visit, under the guidance set by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The primary analysis under the FDA guidance was conducted using a 10% non-inferiority margin in the microbiological intent-to-treat (micro-ITT) population. In the micro-ITT population, the lower and upper bounds of the 95% confidence interval were -7.1% and 5.5%, respectively. Under the EMA guidance, the primary analysis was conducted using a 12.5% non-inferiority margin of the clinically evaluable (CE) patient population. In the CE population, the lower and upper bounds of the 95% confidence interval were -6.3% and 2.8%, respectively. The secondary analyses were consistent with and supportive of the primary outcome.

There were no drug-related serious adverse events in the trial. The most commonly reported drug-related adverse events for eravacycline were gastrointestinal, including nausea (3.3%) and emesis (2.2%). This adverse event profile for eravacycline was consistent with that seen in the Phase 2 clinical trial of eravacycline in cIAI.

The spectrum of pathogens in this trial was similar to that seen in other pivotal trials in this patient population. The most common Gram-negative pathogens in the study included Escherichia coli, Klebsiella pneumonia, Pseudomonas and Bacteroides.

"The prevalence of potentially deadly, multi-drug-resistant bacterial infections has grown rapidly in recent years and is currently a major global public health concern, especially in resistant Gram-negative infections where many current antibiotic treatment options are increasingly ineffective," 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. "These IGNITE 1 trial results suggest that eravacycline has the potential to be a new treatment option for serious intra-abdominal infections, and possibly other serious bacterial infections, where new treatments are urgently needed for patients."

"The positive results from IGNITE 1 underscore that treatment with eravacycline could help a significant number of cIAI patients achieve a clinical cure for their difficult-to-treat Gram-negative infections," said Guy Macdonald, President and CEO of Tetraphase. "The success of this trial is an important milestone for the eravacycline pivotal program. These results, along with those from our ongoing Phase 3 IGNITE 2 trial in complicated urinary tract infections (cUTI) which are expected in mid-2015, would form the basis of regulatory submissions seeking approval for eravacycline in both indications. We continue to target a New Drug Application submission to the FDA by the end of 2015."

Tetraphase plans to submit the data from the Phase 3 IGNITE 1 clinical trial for presentation at a scientific meeting in 2015.

Review Date: 
December 17, 2014