TetraPhase Pharmaceuticals Announces Positive Oral Dosing Data From Lead-in of IGNITE 2 Phase 3 Trial Of Eravacycline In cUTI Support Advancement To Pivotal Portion
9/3/2014 1:09:15 PM
WATERTOWN, Mass.--(BUSINESS WIRE)--Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) today announced that positive top-line results from the lead-in portion of its IGNITE 2 clinical trial, a two-part Phase 3 clinical trial studying the efficacy and safety of intravenous (IV) and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI), support advancement of the trial into its pivotal portion.
Data from the lead-in portion demonstrated that both IV-to-oral dosing regimens of eravacycline (1.5 mg/kg IV followed by 200 mg or 250 mg) compared favorably to levofloxicin. The responder outcome (the primary endpoint for the FDA) for the IV-to-oral 200 mg, IV-to-oral 250 mg and levofloxacin groups were 70.8%, 64.3% and 52.2%, respectively.
Help employers find you! Check out all the jobs and post your resume.
comments powered by