Zavante Therapeutics Presents Additional Clinical And Microbiologic Data From Zolyd Phase II/III Trial At ID Week 2017
Published: Oct 04, 2017
SAN DIEGO, Oct. 4, 2017 /PRNewswire/ -- Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, is presenting at ID Week 2017 additional data from the company's ZEUS Phase 2/3 clinical trial evaluating the investigational antibiotic ZOLYD (fosfomycin for injection, also known as ZTI-01) in hospitalized patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). A post-hoc analysis of the microbiologic data from the ZEUS study demonstrated an increased treatment difference at the test-of-cure visit in favor of ZOLYD compared to previously reported topline results.
"In the pivotal ZEUS study results we reported in April, ZOLYD met the primary endpoint of non-inferiority to piperacillin/tazobactam in patients with complicated urinary tract infections. In a post-hoc analysis using molecular identity techniques performed on pathogens from both treatment arms, ZOLYD demonstrated higher rates of efficacy. We believe this analysis adds to the body of evidence that supports our forthcoming new drug application for U.S. registration," said Evelyn J. Ellis-Grosse, Ph.D., Chief Scientific Officer of Zavante Therapeutics.
ZEUS was a multicenter, randomized, double-blind Phase 2/3 non-inferiority trial designed to evaluate the safety and efficacy of ZOLYD for the treatment of hospitalized adults with cUTI, including AP, versus piperacillin/tazobactam. ZOLYD met the primary endpoint of statistical non-inferiority compared to piperacillin/tazobactam, with an overall success rate of 64.7% (119/184 patients) versus 54.5% (97/178 patients), respectively, a treatment difference of 10.2% (95% CI: -0.4, 20.8). Clinical cure rates were high and similar between treatment groups (90.8% vs. 91.6%, respectively). (Poster 1845)
A post-hoc analysis using pulsed-field gel electrophoresis was performed to confirm the unique molecular identity of baseline and test-of-cure pathogens present in both the ZOLYD and control arms, to confirm eradication at the pathogen strain level. In this analysis, ZOLYD demonstrated an increased treatment difference compared to piperacillin/tazobactam, with an overall success rate of 69.0% versus 57.3%, respectively, in the microbiologic-modified intent-to-treat population at the test-of-cure visit (Day 19). The lower bound of the 95% confidence interval around the treatment difference was greater than zero (treatment difference 11.7%, 95% CI: 1.3, 22.1). (Poster 1833)
"Drug resistance has increased steadily and limits the choices physicians have when treating life-threatening infections in hospitalized patients," said Keith S. Kaye, M.D., M.P.H., Professor of Medicine, University of Michigan Health System. "Intravenous fosfomycin has been extensively used outside the U.S. to treat infections. In the ZEUS study, ZOLYD was well tolerated and is effective for the treatment of patients with complicated urinary tract infections including acute pyelonephritis. It would be a welcome addition to our antibiotic options."
The ID Week oral and poster presentations also feature the ZEUS safety data 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 are also being presented at the meeting.
The schedule of these select ZOLYD data presentations at ID Week is provided below. For additional ZOLYD presentations at ID Week 2017, visit Zavante's website. The complete program can be accessed at the ID Week 2017 website at www.idweek.org.
Saturday, October 7, 2017, 12:30 p.m. 2:00 p.m.
Session 231 Clinical Study with New Antibiotics and Antifungals
- 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 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 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)
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.
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