ZOLYD™ is an investigational, first-in-class epoxide antibiotic with a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR strains that threaten hospitalized patients. The company believes that these attributes, along with extensive positive clinical experience outside of the U.S., support ZOLYD as a first-line treatment for complicated urinary tract infections suspected to be caused by MDR pathogens. Non-clinical data have shown that ZOLYD acts synergistically with certain other antibiotics to improve bacterial killing and restore susceptibility to agents otherwise demonstrating resistance.
The ZOLYD development program is initially focused on obtaining regulatory approval for the treatment of cUTI, including acute pyelonephritis, with the pivotal ZEUS™ study (ZTI-01 Efficacy and Safety study). Approximately 25% of cUTIs are caused by MDR bacteria with limited treatment options available. Fosfomycin IV has an extensive history from markets outside the U.S., where it has been utilized for over 40 years in nine indications. ZOLYD utilizes a new dosing approach to optimize the compound’s pharmacokinetics and pharmacodynamics.