23 January 2017 - - US-based biopharmaceutical company Zavante Therapeutics, Inc has completed patient recruitment and treatment in the ZEUS multinational pivotal clinical trial of TI-01 (fosfomycin for injection), the company said.

ZTI-01 is an investigational antibiotic intended for the treatment of hospitalized patients with complicated urinary tract infections, including acute pyelonephritis.

The company's lead product candidate, ZTI-01 is a first-in-class, broad spectrum intravenous antibiotic under development in the US to treat serious infections, including those caused by MDR Gram-negative pathogens.

ZTI-01 is a first-in-class injectable antibiotic with a mechanism of action that differs from all other antibiotics. ZTI-01 has demonstrated a broad spectrum of bactericidal activity in vitro against both Gram-negative and Gram-positive bacteria, including activity against most contemporary MDR strains. 

FDA granted Fast Track designation and Qualified Infectious Disease Product designation for the investigation of ZTI-01 for cUTI, Hospital-Acquired Bacterial Pneumonia, Ventilator-Associated Bacterial Pneumonia, Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Complicated Intra-Abdominal Infections.

ZEUS (ZTI-01 Efficacy and Safety Study) is the pivotal study intended by Zavante to support an NDA for ZTI-01 in the US.

The first site was initiated in April 2016, the first patient was randomized in 7 July 2016, and last patient visit was completed on 12 January 2016.

The study (ZTI-01-200) is titled "Multi-center, randomised, double-blind, comparative study to evaluate the safety and efficacy of ZTI-01 vs. piperacillin/tazobactam in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults."

Zavante Therapeutics is a privately-held, late clinical-stage biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalised patients.