Zavante Announces FDA Endorsed ZTI-01 Development Plan to Include a Single Pivotal Trial

Qualified Infectious Disease Product Designation Expanded and Fast Track Designation Granted

Dec 16, 2015, 09:00 ET from Zavante Therapeutics, Inc.

SAN DIEGO, Dec. 16, 2015 /PRNewswire/ -- Zavante Therapeutics, Inc., a privately-held, late stage clinical biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for a clinical study under the Company's Investigational New Drug application for its lead product ZTI-01 (fosfomycin for injection) to proceed. Specifically, the FDA has endorsed a clinical development plan that includes a single pivotal trial in complicated urinary tract infections (cUTI). In addition, the FDA granted four Qualified Infectious Disease Product (QIDP) designations and granted Fast Track designations for four ZTI-01 indications including cUTI. The Company also reported that it closed a financing of more than $10 million. Zavante expects to begin the pivotal clinical trial in the first quarter of 2016.

"We are very pleased to achieve these important regulatory milestones and thankful to be working with regulatory authorities and infectious disease thought leaders to bring this important new innovative clinical candidate to the market," said Ted Schroeder, chief executive officer of Zavante. "These new FDA designations combined with the completion of our additional financing round provide important steps towards advancing our corporate goals."  

The clinical study is entitled "Multi-center, randomized, double-blind, comparative study to evaluate the safety and efficacy of ZTI-01 vs. piperacillin/tazobactam in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults."

Lead Product, ZTI-01 is a novel injectable antibiotic with a broad spectrum of bactericidal Gram-negative and Gram-positive activity including potent activity against the increasingly problematic ESBL-producing and Carbapenem Resistant Enterobactericeae (CRE). In September 2014, the FDA initially granted QIDP designation for ZTI-01 for the indication of cUTI. In December 2015, the FDA expanded the QIDP designations to include the following indications: complicated intra-abdominal infections (cIAI), hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP), and acute bacterial skin and skin structure infections (ABSSSI). The QIDP designations should enable Zavante to benefit from certain incentives for the development of new antibiotics, including priority review, and a five-year extension of market exclusivity under the GAIN Act.

The FDA's Fast Track program is designed to facilitate and expedite development and review of new drugs to treat serious or life-threatening conditions and address unmet medical need. Fast track process has been granted to ZTI-01 for the following indications: cUTI, cIAI, HABP/VABP and ABSSSI.

About ZTI-01 (fosfomycin for injection)

The lead product candidate, ZTI-01, is a novel injectable antibiotic with a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR strains where current therapeutic choices are severely limited.

About Zavante Therapeutics, Inc.

Zavante Therapeutics, Inc. is a privately-held, clinical late-stage biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients. The lead product candidate, ZTI-01, is a novel injectable antibiotic with a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR strains where current therapeutic choices are severely limited.

Additional information is available at www.zavante.com.

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SOURCE Zavante Therapeutics, Inc.



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