SAN DIEGO, Sept. 8, 2017 /PRNewswire/ -- Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, has signed a Clinical Trial Agreement with the National Institute of Allergy and Infectious Disease (NIAID) to evaluate Zavante's investigational antibiotic ZOLYD™ (fosfomycin for injection, also known as ZTI-01). The clinical trial is designed to assess the intrapulmonary penetration and pharmacokinetics of ZOLYD to support future development as a treatment for U.S. patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) infections. The U.S. Food and Drug Administration (FDA) has granted Fast Track and Qualified Infectious Disease Product (QIDP) designations to ZOLYD for both indications.
HABP and VABP constitute the most common causes of death among all hospital-acquired infections, with a combined mortality rate of up to 33%. HABP and VABP are the leading causes of nosocomial infection in the U.S., with more than 157,000 patients infected in acute-care hospitals in 2011, according to most recent data from the Centers for Disease Control and Prevention. The main risk factors for hospital-acquired pneumonia are intubation and mechanical ventilation.
"We believe that NIAID's trial is an important step in establishing ZOLYD's potential clinical utility for treating patients in the U.S. with bacterial pneumonia," said Evelyn J. Ellis-Grosse, Ph.D., Chief Scientific Officer of Zavante Therapeutics. "As resistance to currently available antimicrobials has reached alarmingly high levels, it's becoming more challenging to treat deep-seated respiratory infections, particularly those caused by Gram-negative bacteria. New broad-spectrum agents with complementary novel mechanisms of action and favorable pulmonary penetration would be welcome additions to the treatment armamentarium."
NIAID, part of the National Institutes of Health, plans to initiate a Phase 1 trial in the fourth quarter of 2017 to determine the intrapulmonary pharmacokinetics of ZOLYD after multiple doses in 36 healthy subjects. This trial will be conducted by the Vaccine and Treatment Evaluation Unit (VTEU) at Duke University (Contract #HHSN272201300017I). The network of VTEUs is supported by NIAID. Zavante will supply the investigational product that will be tested in this trial. The trial will measure ZOLYD's pulmonary penetration by assessing drug concentrations in the lining of subjects' bronchial pathways. Diffusion and saturation of antibiotics in patients' airways are considered important factors in a drug's ability to effectively treat lower-respiratory tract infections. Prior preclinical and clinical investigations of intravenous fosfomycin demonstrate that it penetrates rapidly into tissues and achieves clinically relevant concentrations in serum, urine, soft tissues, lungs and other organs, potentially making it a versatile antibiotic treatment option. The NIAID-supported trial will also seek to provide additional data regarding the safety and tolerability of a contemporary dosing regimen (6 grams every 8 hours), which may support further evaluations of ZOLYD in the intended patient populations.
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 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 Phase 2/3 clinical trial in hospitalized adults with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). The company plans to submit a New Drug Application to the FDA in early 2018.
The FDA has granted Fast Track and QIDP designations for the investigation of ZOLYD for cUTI, HABP/VABP, 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 "may," "believe," "plans," and similar words. Forward-looking statements contained in this press release include statements about the potential for the Phase 1 NIAID clinical trial of ZOLYD to support ZOLYD's clinical utility for treating patients in the U.S. with bacterial pneumonia, and the company's plans and timing for submitting an NDA for, and commercializing, 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 Phase 1 NIAID clinical trial will produce data that supports the clinical utility of ZOLYD in treating patients in the U.S. with bacterial pneumonia; whether the results of the company's ZEUS clinical trial are deemed to be sufficient by FDA 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 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 and ZAVANTE are trademarks or registered trademarks of Zavante Therapeutics, Inc.
SOURCE Zavante Therapeutics, Inc.