Zavante Therapeutics To Present ZOLYD™ Data From Pivotal ZEUS Study At ID Week 2017
SAN DIEGO, Sept. 20, 2017 /PRNewswire/ -- Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, and its research collaborators will present eight posters related to investigational antibiotic ZOLYD™ (fosfomycin for injection, also known as ZTI-01), at ID Week 2017 to be held October 4-8, 2017 in San Diego.
"Zavante welcomes the opportunity to present in a peer review forum detailed results from our pivotal ZEUS Phase 2/3 clinical trial," said Evelyn J. Ellis-Grosse, Ph.D., Chief Scientific Officer of Zavante Therapeutics. "In the ZEUS study, ZOLYD met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with complicated urinary tract infections, and we believe these data support our forthcoming new drug application for U.S. registration."
ZEUS was a multicenter, randomized, double-blind Phase 2/3 trial designed to evaluate the safety and efficacy of ZOLYD for the treatment of hospitalized adults with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), versus piperacillin/tazobactam. New positive ZEUS results to be presented at ID Week include a post-hoc analysis of the primary outcome (defined as clinical cure plus microbiologic eradication at the test-of-cure visit) based upon molecular strain typing of bacterial pathogens in both treatment arms.
The ID Week poster presentations also feature the ZEUS safety and efficacy data in a subset of patients with infections caused by resistant bacteria. In vitro studies evaluating activity of ZOLYD combined with meropenem or cefepime in different resistance models will also be presented at the meeting.
In addition to the company's poster presentations, Dr. Ellis-Grosse will participate in a symposium titled, "New Antibiotics: What's in the Pipeline?" on Thursday, October 5th, from 2:00 p.m. to 3:30 p.m. Pacific Time and a meet-the-professor session titled, "Pipeline 2.0," on Friday, October 6th, from 7:00 a.m. to 8:15 a.m. Pacific Time.
Poster details for the meeting are as follows. The complete program can be accessed at the ID Week 2017 website at www.idweek.org.
Friday, October 6, 2017, 12:30 p.m. – 2:00 p.m.
Session 147 – Expanded Spectrum - New Antimicrobial Susceptibility Testing
- Poster 1224: In vitro Activity of Fosfomycin, Alone and Combined with Cefepime and Meropenem, Against Carbapenemase-Producing Gram-Negative Bacteria
Session 167 – Preclinical Study with New Antibiotics and Antifungals
- Poster 1517: ZTI-01 Treatment Improves Survival of Animals Infected with Multidrug Resistant Pseudomonas aeruginosa
- Poster 1523: Fosfomycin (FOS) Plus Meropenem (MER) Suppresses Resistance Emergence Against P. aeruginosa (PA) PAO1 in the Hollow Fiber Infection Model (HFIM)
Saturday, October 7, 2017, 12:30 p.m. – 2:00 p.m.
Session 231 – Clinical Study with New Antibiotics and Antifungals
- Poster 1830: Phenotypic Antibiotic Resistance in ZEUS: Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 versus Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP)
- Poster 1833: Per Pathogen Outcomes from the ZEUS study, a Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 (fosfomycin for injection) versus Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP)
- Poster 1837: Safety Results from the ZEUS Study: Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults with Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP) who Received Intravenous Fosfomycin (ZTI-01)
- Poster 1845: Intravenous Fosfomycin (ZTI-01) for the Treatment of Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP): Results from a Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults (ZEUS)
- Poster 1848: Population Pharmacokinetic (PPK) Analysis of ZTI-01 (Fosfomycin for Injection) Using Data from Healthy Subjects and Patients with Complicated Urinary Tract Infections (cUTI)
About ZOLYD (fosfomycin for injection, also known as ZTI-01)
ZOLYD is an investigational, first-in-class injectable epoxide antibiotic with a broad spectrum of activity in vitro against Gram-negative and Gram-positive bacteria, including activity against most multi-drug resistant strains that are of particular concern to public health. ZOLYD has a differentiated mechanism of action that acts at an earlier step in cell wall synthesis inhibition, providing activity against pathogens that are often resistant to other classes of antibiotics. Zavante recently reported that ZOLYD met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the pivotal ZEUS clinical trial in hospitalized patients with cUTI, including AP.
The U.S. Food and Drug Administration has granted Fast Track and Qualified Infectious Disease Product designations for the investigation of ZOLYD for cUTI, hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP) infections, acute bacterial skin and skin structure infections (ABSSSI), and complicated intra-abdominal infections (cIAI). These designations make ZOLYD eligible for certain incentives available for the development of new antibiotics, including priority FDA review and an additional five years of market exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act.
ZOLYD is an investigational medication that has not been approved by the FDA for any indication.
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. Such statements may be preceded by the words such as "believe" and similar words. Forward-looking statements contained in this press release include statements about the company's belief that data from the ZEUS study will be sufficient to support a new drug application (NDA) for U.S. registration of ZOLYD. 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 the company's actual results to differ materially from those indicated in this release include, among others, the following: whether the results of the ZEUS clinical trial are deemed by FDA to be sufficient to support approval of an NDA for ZOLYD in the treatment of patients with cUTI; unanticipated delays that may occur, or unanticipated findings that may emerge, in analyzing the safety or efficacy data from the ZEUS clinical trial; the company's ability to successfully complete necessary manufacturing and related development activities for ZOLYD on time and at reasonable costs; the company's ability to obtain additional financing required to complete development activities and prepare for the commercialization of ZOLYD, if approved by FDA; and potential changes in the FDA's regulatory policies that could negatively impact FDA approval of an NDA for ZOLYD or the Fast Track or QIDP designations granted by FDA for ZOLYD. 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.
ZOLYD and ZAVANTE are trademarks or registered trademarks of Zavante Therapeutics, Inc.
SOURCE Zavante Therapeutics, Inc.
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