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.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

“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.

Clinical Trials Arena Excellence Awards - Have you nominated?

Nominations are now open for the prestigious Clinical Trials Arena Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact. This is your chance to showcase your achievements, highlight industry advancements, and gain global recognition. Don't miss the opportunity to be honoured among the best - submit your nomination today!

Nominate Now