Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced completion of enrollment in IGNITE3, its ongoing phase 3 clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to ertapenem in complicated urinary tract infections (cUTI). The Company expects to report top-line data from this trial in the first quarter of 2018.
“We have now completed enrollment of approximately 1,200 patients in IGNITE3, well ahead of schedule, and we expect top-line data from IGNITE3 to be available during the first quarter of 2018,” said Guy Macdonald, President and CEO of Tetraphase. “In parallel, we are working to prepare a New Drug Application (NDA) for twice-daily IV eravacycline in complicated intra-abdominal infections, which will be comprised of data from the successfully completed phase 3 IGNITE1 and IGNITE4 clinical trials. Assuming a positive outcome from IGNITE3 and approval of IV eravacycline for the treatment of cIAI, we plan to file a supplemental NDA (sNDA) for IV eravacycline as a new treatment for patients with cUTI.”
Mr. Macdonald added, “With high rates of quinolone resistance in hospitals in the U.S. and around the world, we believe a once-daily IV therapy for cUTI could be an important new treatment option for patients who are eligible for completing their course of antibiotics in an outpatient setting.”