IGNITE3 trial completes patient enrollment for eravacycline in cUTIs
Tetraphase Pharmaceuticals has completed enrollment in IGNITE3, an ongoing phase 3 clinical trial comparing the efficacy and safety of once-daily IV eravacycline with ertapenem for the treatment of complicated urinary tract infections, according to a press release.
Eravacycline, an antibiotic created to combat multidrug-resistant pathogens, is currently in development for the treatment of complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs), according to the release. IGNITE3 has currently enrolled approximately 1,200 patients who were randomly assigned 1:1 to receive once-daily IV eravacycline or ertapenem — which is marketed under the brand name Invanz (Merck) — for a minimum of 5 days. After this time, eligible patients will transition over to an appropriate oral agent. The company expects to report top-line data from IGNITE3 by early 2018.
Data from the IGNITE2 clinical trial showed higher response rates among patients with cUTIs who stayed on IV eravacycline compared with those who switched from IV to oral levofloxacin. However, an IV-to-oral regimen of eravacycline was inferior to IV-to-oral levofloxacin in that study. Meanwhile, findings from the IGNITE1 and IGNITE4 trials demonstrated that twice-daily IV eravacycline was noninferior to comparators ertapenem and meropenem in patients with cIAIs.
While IGNITE3 is underway, Tetraphase will also prepare a new drug application for twice-daily IV eravacycline in cIAIs using data from the IGNITE1 and IGNITE4 trials, according to the release. With positive results from the IGNITE3 trial and approval of IV eravacycline for the treatment of cIAIs, the company plans to file a supplemental application for IV eravacycline as a new treatment for patients with cUTIs, the release said.
“Rates of quinolone resistance in hospitals in the U.S. and around the world continue to rise, limiting the effectiveness of available treatments,” Guy Macdonald, CEO of Tetraphase, told Infectious Disease News. “Soon, Tetraphase will have phase 3 data from a large patient pool on a once-daily IV therapy for complicated urinary tract infections. If eravacycline is approved by the FDA, it would represent a new treatment option, particularly for patients eligible for completing their course of antibiotics in an outpatient setting, which would be good news for clinicians.” – by Savannah Demko
Disclosure: Macdonald is CEO of Tetraphase.