US-based biopharmaceutical firm Zavante Therapeutics has randomised the first patient in the Zeus pivotal clinical study of ZTI-01 (fosfomycin for injection) to treat complicated urinary tract infections (cUTI), including acute pyelonephritis.
ZTI-01 is the company’s investigational broad spectrum IV antibiotic being developed to treat infections, as well as those caused by multidrug resistant pathogens.
ZEUS is a multi-centre, randomised, double-blind and comparative study designed to evaluate the safety and efficacy of ZTI-01 when compared with piperacillin / tazobactam, to treat hospitalised adults afflicted with cUTI including acute pyelonephritis.
The study commenced in April this year and is expected to involve approximately 460 hospitalised patients.
Zavante founder, president and CEO Ted Schroeder said: "Randomisation of our first patient in the ZEUS study is an important clinical milestone for Zavante.
"We anticipate filing a New Drug Application, or NDA, for ZTI-01 with the US Food and Drug Administration late in the second half of 2017.
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“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 US fighting serious infections, including those caused by multidrug-resistant (MDR) pathogens in the hospital setting."
ZTI-01 has exhibited a wide range of bactericidal Gram-negative and Gram-positive activity, as well as being active against the contemporary MDR bacterial strains and thereby addressing the limited antibiotic therapeutic choice against infections.