Eravacycline fails to meet endpoint in IGNITE 2 study for complicated urinary tract infections- Tetraphase
Tetraphase Pharmaceuticals announced that the IGNITE2 phase III clinical trial of eravacycline administered as an IV-to-oral transition therapy for the treatment of complicated urinary tract infections (cUTI) did not achieve its primary endpoint of statistical non-inferiority compared to levofloxacin.
Comment: The result was unexpected and disappointing, since eravacycline was shown to be superior to Invanz (ertapenem) from Merck Inc. in the Phase III IGNITE1 trial for the treatment of complicated intra-abdominal infections (cIAI). However, individuals in IGNITE1 were treated solely with an IV formulation of the antibiotic, while people treated with eravacycline in the 908-patient IGNITE2 study were given IV and oral doses of the antibiotic.
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