Zavante Therapeutics Reports Completion of Patient Treatment in the Zeus Study of ZTI-01 (fosfomycin for injection) for the Treatment of Complicated Urinary Tract Infections

1/19/2017

  • Patient enrollment and treatment in pivotal ZEUS clinical trial completed
    ahead of schedule
  • Zavante expects to submit a New Drug Application (NDA) to the FDA in the
    second half 2017
  • FDA has granted ZTI-01 Qualified Infectious Disease Product (QIDP)
    designation, as authorized under the GAIN Act, and granted Fast Track Status
  • ZTI-01 development program targets urgent and growing threat of
    multidrug-resistant (MDR) Gram-negative pathogens

SAN DIEGO, CA – January 19, 2017 – Zavante Therapeutics, Inc., a privately-held, late clinical-stage biopharmaceutical company, today announced the completion of patient recruitment and treatment in the ZEUS multinational pivotal clinical trial of  TI-01 (fosfomycin for injection).  ZTI-01 is an investigational antibiotic intended for the treatment of hospitalized patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). ZTI-01, the Company’s lead product candidate, is a first-in-class, broad spectrum intravenous antibiotic under development in the U.S. to treat serious infections, including those caused by MDR Gram-negative pathogens.

“We are pleased to conclude this study ahead of schedule and we thank all of the participating Investigators and their study patients,” said Evelyn J. Ellis-Grosse, Ph.D., Chief Scientific Officer of Zavante. “The ZEUS study enrolled quickly in five months since first site initiation, with a total of 465 patients randomized and treated at 91 sites globally. We expect to file a New Drug Application, or NDA, for ZTI-01 in the second half of 2017.”

About ZTI-01 (fosfomycin for injection)
ZTI-01 is a first-in-class injectable antibiotic with a mechanism of action that differs from all other antibiotics. ZTI-01 has demonstrated a broad spectrum of bactericidal activity in vitro against both Gram-negative and Gram-positive bacteria, including activity against most contemporary MDR strains. FDA granted Fast Track designation and Qualified Infectious Disease Product (QIDP) designation for the investigation of ZTI-01 for the following indications: cUTI, Hospital-Acquired Bacterial Pneumonia (HABP), Ventilator-Associated Bacterial Pneumonia (VABP), Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Complicated Intra-Abdominal Infections (cIAI)

About the ZEUS Study
ZEUS (ZTI-01 Efficacy and Safety Study) is the pivotal study intended by Zavante to support an NDA for ZTI-01 in the U.S. The first site was initiated in April 2016, the first patient was randomized in July 7, 2016, and last patient visit was completed on January 12, 2017. The study (ZTI-01-200) is titled “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.”  More clinical trial information is available at  www.clinicaltrials.gov.

About Zavante Therapeutics, Inc.
Zavante Therapeutics, Inc. is a privately-held, late clinical-stage biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients.

Additional information is available at www.zavante.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of U.S. federal securities laws. Words such as “expects,” “intended,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include statements about the anticipated effectiveness of ZTI-01 in treating serious infections in hospitalized patients, including those caused by MDR pathogens, and the company’s plans and timing for submitting an NDA for ZTI-01. Forward-looking statements are not historical facts or assurances of the company’s future performance, but are based on management’s current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and may be outside of the company’s control.  Because the company’s actual results and financial condition may differ materially from those indicated in the forward-looking statements, you should not rely on any such forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in this release include, among others, the following: whether the results of our ZEUS clinical trial are positive and are deemed to be sufficient by FDA to support approval of an NDA for ZTI-01, unanticipated delays that may occur in analyzing the data from the ZEUS clinical trial, our ability to successfully complete necessary manufacturing and related development activities for ZTI-01 on time and at reasonable costs, our ability to obtain additional financing required to complete development activities and prepare for the commercialization of ZTI-01, and potential changes in the FDA’s regulatory policies that could negatively impact the approval of the company’s NDA for ZTI-01 or the Fast-track or QIDP designations granted by FDA for ZTI-01. Forward-looking statements contained in this press release are based only on information currently available to the company and speak only as of the date made. Zavante undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact:
Kevin Finney
Zavante Therapeutics
kfinney@zavante.com
858-299-4990

Media Contact:
Amy Caterina
Zavante Therapeutics
acaterina@zavante.com
619-379-0054