Zavante recruits first patient in Zeus study of ZTI-01 to treat cUTI
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.
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.
"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."
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.
“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.