Phase III trials success for eravacycline treatment for Urinary Tract Infections-TetraPhase

Tetraphase Pharmaceuticals, Inc. announced that positive top-line results from the lead-in portion of its IGNITE 2 clinical trial , a two-part Phase III 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 favourably 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. The microbiological response (the primary endpoint for the European Medicines Agency) were 75.0%, 64.3% and 56.5%, respectively. The pharmacokinetics of both oral doses of eravacycline were comparable to the IV formulation. Overall, treatment was generally well tolerated in all three groups with the most common adverse events reported being nausea and emesis. Only two patients discontinued treatment as a result of drug related adverse events.