Zavante Therapeutics has initiated the ZTI-01 Efficacy and Safety (ZEUS) study for the company’s ZTI-01, a fosfomycin for injection and an antibiotic designed to treat hospitalised patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).
The currently under development ZTI-01 is a broad spectrum IV antibiotic designed to treat serious infections, including those caused by multidrug-resistant (MDR) pathogens.
Zavante Therapeutics expects to complete the ZEUS study in the second half of next year.
The company noted that ZEUS is a multi-national, randomised, active-controlled, double-blind study that will provide data to support the use of ZTI-01 to address the unmet medical need of treating cUTI, including patients with MDR infections.
It is expected that around 110 clinical sites will participate in the study to enrol 460 hospitalised patients with cUTI, including AP.
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’, the study is claimed to be the single study intended to support an NDA for ZTI-01 in the US.
Zavante Therapeutics founder, president and CEO Ted Schroeder said: "The closing of our Series A financing has provided us with financial resources that we believe will be sufficient to initiate and complete the ZEUS study, with a goal of filing a New Drug Application, or NDA, for ZTI-01 with the US Food and Drug Administration (FDA) late in the second half of 2017."
The company stated that ZTI-01 has demonstrated a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR bacterial strains, which current antibiotic therapeutic choices are severely limited for.
In 2014, the FDA initially granted Qualified Infectious Disease Product (QIDP) designation for ZTI-01 for the indication of cUTI and last year, the FDA expanded the QIDP designations for ZTI-01 to include complicated intra-abdominal infections (cIAI), hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP), and acute bacterial skin and skin structure infections (ABSSSI).
Besides, the FDA granted fast-track designations for all four QIDP designations, making ZTI-01 eligible for certain incentives available for the development of new antibiotics, including priority FDA review and an additional five-years of market exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act.