Zolyd (fosfomycin for injection) meets primary endpoint in pivotal phase II/III trial in complicated urinary tract infections- Zavante Therapeutics

Zavante Therapeutics announced that Zolyd (fosfomycin for injection, also known as ZTI-01), met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam 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 II/III trial designed to evaluate the safety and efficacy of Zolyd in the treatment of hospitalized adults with cUTI or AP. The primary endpoint of overall success, defined as clinical cure plus microbiologic eradication, was assessed in the microbiologic-modified intent-to-treat population at the test-of-cure visit (Day 19). 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). Clinical cure rates were high and similar between treatment groups (90.8% vs. 91.6%, respectively).

Zolyd is a first-in-class injectable epoxide antibiotic with a differentiated mechanism of action and broad spectrum of activity against Gram-negative and Gram-positive pathogens, including multi-drug resistant (MDR) pathogens. Zavante plans to present the complete ZEUS study results at an upcoming infectious disease conference, and expects to submit a new drug application to the U.S. Food and Drug Administration in early 2018.