SAN DIEGO, July 11, 2016 /PRNewswire/ -- Zavante Therapeutics, Inc., a privately held, late clinical-stage biopharmaceutical company, today announced that the first patient has been randomized in the ZEUS (ZTI-01 Efficacy and Safety) study. Initiated in April 2016, ZEUS is a pivotal clinical study of ZTI-01 (fosfomycin for injection), an investigational antibiotic designed to treat hospitalized patients with complicated urinary tract infections, including acute pyelonephritis. ZTI-01, the Company's lead product candidate, is a first-in-class, broad spectrum IV antibiotic under development to treat serious infections, including those caused by multidrug resistant pathogens. The Company expects to complete enrollment of the ZEUS study in the first half of 2017.
"Randomization of our first patient in the ZEUS study is an important clinical milestone for Zavante," said Ted Schroeder, founder, president and chief executive officer of Zavante. "We anticipate filing a New Drug Application, or NDA, for ZTI-01 with the U.S. Food and Drug Administration late in the second half of 2017. We are excited to introduce ZTI-01 as a new class of injectable antibiotics that we hope will be a valuable tool for physicians in the U.S. fighting serious infections including those caused by multidrug-resistant pathogens in the hospital setting."
ZEUS is the pivotal study intended to support an NDA for ZTI-01 in the U.S. The study is titled "Multi-center, randomized, 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." More clinical trial information is available at www.clinicaltrials.gov.
About Zavante Therapeutics, Inc.
Zavante is a privately-held, late clinical-stage biopharmaceutical company focused on licensing, developing and commercializing novel products that address serious unmet medical needs in the hospital.
Additional information is available at www.zavante.com.
ZAVANTE and ZAVANTE THERAPEUTICS are registered trademarks of Zavante Therapeutics, Inc.
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SOURCE Zavante Therapeutics, Inc.