Zavante's Zolyd meets in pivotal cUTI study

Zavante Therapeutics Inc. (San Diego, Calif.) said Zolyd fosfomycin (ZTI-01) met the primary endpoint in the Phase II/III ZEUS trial to treat complicated urinary tract infections (cUTIs). The company plans to submit an NDA to FDA for the candidate in early 2018.

Zolyd was non-inferior to piperacillin/tazobactam in the proportion of patients who achieved clinical cure plus microbiologic eradication in the microbiological modified intent-to-treat population (mITT) at the test-of-cure (TOC) visit on day 19, meeting ZEUS's primary endpoint (64.7% vs. 54.5%). Zavante also said clinical cure rates were similar between treatment arms (90.8% vs. 91.6%)...