Zavante Therapeutics, Inc., a privately held, late clinical-stage biopharmaceutical company, announced that it has initiated the ZEUS (ZTI-01 Efficacy and Safety) study. ZEUS is a pivotal clinical study for ZTI-01 (fosfomycin for injection), an antibiotic designed to treat hospitalized patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). ZTI-01, the company’s lead product candidate, is a first-in-class, broad spectrum I.V. antibiotic under development to treat serious infections, including those caused by multidrug-resistant (MDR) pathogens. The company expects to complete the ZEUS study in the second half 2017.
“Initiation of our pivotal study for ZTI-01 is an important milestone for Zavante and demonstrates the implementation expertise of our management team,” said Ted Schroeder, founder, president and CEO of Zavante “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. 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 a multi-national, randomized, active-controlled, double-blind study that is expected to provide substantive data to support the use of ZTI-01 to address the unmet medical need of treating cUTI, including patients with MDR infections. It is anticipated that approximately 110 clinical sites will participate in the study to enroll 460 hospitalized patients with cUTI, including AP. ZEUS is the single pivotal study intended to support an NDA for ZTI-01 in the US. 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.”
“The lack of available and effective antibiotics for these life threatening multidrug-resistant pathogens has created an important unmet medical need that is widely acknowledged by national medical agencies and societies,” said George Drusano, M.D., professor of medicine and director of the Institute for Therapeutic Innovation, Department of Medicine in the College of Medicine at the University of Florida.
“An antibiotic with a unique mechanism of action like ZTI-01 would be an important addition to our antibacterial armamentarium when treating seriously ill patients in the hospital. For the most seriously ill patients, the potential for ZTI-01 to interact positively in combination with antibiotics of other classes is a real plus.”
ZTI-01 is a first-in-class injectable epoxide antibiotic that has demonstrated a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR bacterial strains, for which current antibiotic therapeutic choices are severely limited. In September 2014, the FDA initially granted Qualified Infectious Disease Product (QIDP) designation for ZTI-01 for the indication of cUTI. In December 2015, 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). Additionally, the FDA granted fast-track designations for all four QIDP designations. These QIDP designations make 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.