Zavante Therapeutics said it expects to file an NDA with the FDA during early 2018 for its injectable epoxide antibiotic, ZOLYD™ (fosfomycin for injection; ZTI-01), on the back of positive data from the pivotal ZEUS™ study.
The reported Phase II/III trial, in 465 patients with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP), compared ZOLYD therapy with treatment using piperacillin/tazobactam. The study met its primary endpoint of non-inferiority of ZOLYD, with overall success defined as clinical cure plus microbiological eradication. The overall success rate with ZOLYD was 64.7%, compared with 54.5% for piperacillin/tazobactam therapy. The clinical cure rates were similar, at 90.8% for ZOLYD, and 91.6% for the comparator group. Full data from the ZEUS trial will be presented at a forthcoming infectious diseases conference.
Fosfomycin has been used outside the U.S. for more than 40 years for multiple indications, Zavante notes, but the drug has yet to be approved by the FDA for any indication. “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,” commented Ted Schroeder, president and CEO at Zavante. ” We expect to file our NDA in early 2018 and, if approved, look forward to introducing ZOLYD for appropriate patients who can benefit from a new antibiotic therapy.”
“In an environment of rapidly increasing resistance, safe and effective antibiotics with activity against multi-drug-resistant pathogens are sorely needed,” added Keith Kaye M.D., professor of medicine, University of Michigan. “If approved, ZOLYD's unique mechanism of action and broad spectrum of activity would add to the treatment armamentarium when treating seriously ill patients in the hospital.”
ZOLYD has been granted Fast Track as well as Qualified Infectious Disease Product (QIPD) designation for the cUTI indication, and also for hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), acute bacterial skin and skin structure infections (ABSSSI), and complicated intra-abdominal infections (cIAI).
Founded in 2015, San Diego-based Zavante is developing ZOLYD as a broad-spectrum antibiotic for the treatment of serious hospital infections caused by Gram-negative and Gram-positive bacteria, including clinically relevant multi-drug-resistant strains. The firm raised $45 million in a series A financing round in March 2016.