"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.
Additional information is available at www.zavante.com.
1 AAC http://aac.asm.org/content/early/2016/06/22/AAC.01267-16.full.pdf+html?ijkey=Q1ltC0DR7WBiU&keytype=ref&siteid=asmjournals
2 AAC http://aac.asm.org/content/60/7/4420.full
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SOURCE Zavante Therapeutics, Inc.