SAN DIEGO, Calif., July 12, 2016 /PRNewswire/ -- Zavante Therapeutics, Inc., a privately-held, late clinical stage biotechnology company, today announced that the JMI Laboratories SENTRY surveillance report1 published in Antimicrobial Agents and Chemotherapy (AAC) has identified that a newly emerging bacterial pathogen resistant in vitro to "last defense" antibiotic colistin, has retained susceptibility to the Company's lead product candidate, ZTI-01 (fosfomycin for injection), as well as certain other antibiotics. Confirmation of the U.S. presence of this concerning, multidrug resistant (MDR) pathogen, which has a genetic profile known as mcr-1,2 represents a challenge for hospital-based physicians due to the limited therapeutic options that are currently available.
A first-in-class epoxide intravenous (IV) antibiotic, ZTI-01 has a differentiated mechanism of action and a broad spectrum of antibacterial activity, and is under development to treat complicated urinary tract infections (cUTI), including those caused by MDR pathogens. Zavante recently initiated the ZEUS clinical study of ZTI-01 for the treatment of cUTI in hospitalized patients. The emergence of mcr-1 isolates, which are resistant to many leading, last-resort antibiotics like colistin, highlights the importance of developing IV therapies with differentiated mechanisms of action, such as ZTI-01, for treating patients in the hospital setting.
"When we selected fosfomycin as Zavante's initial development program, we recognized the potential of introducing a new IV antibiotic to the U.S. with a broad spectrum of activity including multidrug resistant pathogens," said Evelyn J. Ellis-Grosse, Ph.D., chief scientific officer of Zavante. "We believe that the recent emergence of this problematic multidrug resistant pathogen (mcr-1 isolates) in the U.S. highlights the urgent need for new classes of IV antibiotics. The JMI SENTRY surveillance report, which indicates that the mcr-1 isolate recently identified in the U.S. retained in vitro susceptibility to fosfomycin, is encouraging. As an agent with a different mechanism of action for killing bacteria, we believe that ZTI-01 is an important product candidate that, if approved, may address an unmet medical need for clinicians treating patients with serious, multidrug resistant bacterial infections."
"The emergence of bacteria with the colistin-resistant mcr-1 gene in the U.S. contributes to the ever-growing threat of multidrug resistant bacteria, and highlights the need for new antibiotics with activity against these pathogens," said Keith Kaye M.D., M.P.H., corporate vice president of Quality, Infection Prevention and Antimicrobial Stewardship at Detroit Medical Center. "The ability to combine antibiotic agents with different mechanisms that further enhance bacterial killing may provide an important addition to the therapeutic armamentarium."
Zavante's lead product candidate, ZTI-01, is a first-in-class injectable antibiotic that has demonstrated a broad spectrum of bactericidal Gram-negative and Gram-positive activity in vitro, including activity against most contemporary MDR strains.
FDA granted Fast Track designation and Qualified Infectious Disease Product designation for the investigation of ZTI-01 for the following indications:
Hospital-Acquired Bacterial Pneumonia (HABP)/
Ventilator-Associated Bacterial Pneumonia (VABP)
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Complicated Intra-Abdominal Infections (cIAI)
In April 2016, Zavante initiated the ZEUS study, entitled "Multi-center, randomized, double-blind, comparative study to evaluate the safety and efficacy of ZTI-01 vs. piperacillin/tazobactam in the treatment of complication urinary tract infections, including acute pyelonephritis, in hospitalized adults."
About Zavante Therapeutics, Inc.
Zavante is a privately-held, late clinical stage biopharmaceutical company focused on licensing, developing and commercializing novel products that address serious unmet medical needs in the hospital.