Zavante Therapeutics’ investigational product candidate, Zolyd (fosfomycin for injection, also known as ZTI-01), met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam.
It was tested in the pivotal Zeus clinical trial in patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).
The Zeus study was a multi-center, randomized, double-blind Phase 2/3 trial designed to evaluate the safety and efficacy of Zolyd in the treatment of hospitalized adults with cUTI or AP.
In the study, Zolyd met the primary endpoint of statistical non-inferiority compared to piperacillin/tazobactam, with an overall success rate of 64.7% (119/184 patients) versus 54.5% (97/178 patients), respectively, a treatment difference of 10.2% (95% CI: -0.4, 20.8).
Zavante expects to submit a new drug application to the U.S. Food and Drug Administration in early 2018.
Professor of Medicine, University of Michigan, Keith Kaye, said that Zolyd’s mechanism of action and broad spectrum of activity would add to the treatment armamentarium when treating seriously ill patients in the hospital.
Evelyn J. Ellis-Grosse, Chief Scientific Officer of Zavante Therapeutics, said: “Increasing antimicrobial resistance is significantly limiting the number of therapies available to treat infections in U.S. hospitals.”
“We believe that the results of the Zeus study bring us one step closer to introducing Zolyd as a foundational, broad-spectrum antibiotic in the U.S. hospital market,” said Ted Schroeder, President and Chief Executive Officer of Zavante.