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.
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