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. 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, developed by Zavante, to optimize the compound’s pharmacokinetics and pharmacodynamics.
The company believes that these attributes, along with the positive clinical experience worldwide, support ZOLYD as a first-line treatment for complicated urinary tract infections (cUTI) suspected to be caused by MDR pathogens. Approximately 25% of cUTIs are caused by MDR bacteria and limited treatment options are available. In addition, 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). In the ZEUS study, ZOLYD met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in this patient population. Zavante expects to file a New Drug Application utilizing the FDA’s 505(b)(2) pathway in early 2018.
The FDA has granted ZOLYD Qualified Infectious Disease Product (QIDP) and Fast Track designations for:
- Complicated urinary tract infections (cUTI)
- Complicated intra-abdominal infections (cIAI)
- Hospital-acquired bacterial pneumonia (HABP) /
Ventilator-associated bacterial pneumonia (VABP)
- Acute bacterial skin and skin structure infections (ABSSSI)