SAN DIEGO, CA, June 5, 2017 – Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, today announced that the company and its research collaborators presented data supporting the safety, tolerability and pharmacokinetic profile of investigational product candidate, ZOLYD™ (fosfomycin for injection, also known as ZTI-01), compared to oral fosfomycin, at the ASM Microbe 2017 Meeting. The Phase 1 trial was supported in part by the National Institute of Allergy and Infectious Disease (NIAID) of the National Institutes of Health (NIH). The results of the trial supported the intravenous (IV) dose selection of ZOLYD that was subsequently studied in Zavante’s successful pivotal Phase 2/3 trial.
Research collaborator Eric Wenzler, PharmD, Infectious Diseases Pharmacotherapy Fellow at the University of Illinois at Chicago, presented the poster, “Pharmacokinetics, Safety, and Tolerability of Single Dose Intravenous and Oral Fosfomycin in Healthy Volunteers” (oral poster 153). The trial demonstrated ZOLYD was well tolerated and treatment emergent adverse events were mild-to-moderate and comparable between the treatment groups. No new safety concerns were identified. Pharmacokinetic data demonstrated significant exposures in blood and urine relative to the oral product. These data supported further investigation of ZOLYD in Zavante’s pivotal, double-blind ZEUS™ Phase 2/3 clinical trial, which met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam (4.5 grams) utilizing a 6 gram-dose in hospitalized adults with complicated urinary tract infections, including acute pyelonephritis.
“We believe that we have optimized fosfomycin’s pharmacokinetics and pharmacodynamics to allow for rapid and reliable intravenous delivery of ZOLYD to achieve therapeutic blood levels sufficient to fight the most serious hospital infections,” said Evelyn J. Ellis-Grosse, Ph.D., Chief Scientific Officer of Zavante Therapeutics. “This Phase I study was a critical first step in demonstrating tolerability and obtaining key pharmacokinetic data regarding ZOLYD, which allowed Zavante to quickly advance into a pivotal efficacy trial that has been completed and which met its primary endpoint. We believe ZOLYD can become an important, first-line treatment for hospitalized patients with complicated urinary tract infections suspected to be caused by multi-drug resistant pathogens. Given the concerning unmet medical need in the U.S. for new intravenous antibiotics with differentiated mechanisms of action, we are grateful to NIAID for their support of this study.”
The Phase 1, open-label study evaluated ZOLYD and oral fosfomycin (Monurol®) in 28 healthy adult subjects. Subjects received a single dose of 1 gram ZOLYD, 8 grams ZOLYD, and 3 grams oral fosfomycin in a randomized, crossover fashion.
NIAID provided partial support for this trial under Award Number 1UM1AI104681-01. NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.
Zavante and additional research collaborators presented 10 posters related to ZOLYD at ASM Microbe 2017. A complete list is available at www.Zavante.com and abstracts are available from the ASM Microbe 2017 website.
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 bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR 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.
The U.S. Food and Drug Administration (FDA) granted Fast Track designation and Qualified Infectious Disease Product (QIDP) designation for the investigation of ZOLYD 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). 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. Words such as “believes” and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include statements about the company’s beliefs regarding ZOLYD’s ability to rapidly and reliably achieve blood levels sufficient to treat serious infections in hospitalized patients, and to become an important, first-line treatment for hospitalized patients with cUTIs, including those caused by MDR pathogens. 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 to be sufficient by FDA to support approval of an NDA for ZOLYD; unanticipated delays that may occur, or unanticipated findings that may emerge, in analyzing the 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 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, ZEUS and ZAVANTE are trademarks or registered trademarks of Zavante Therapeutics, Inc.
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