11 September 2017 - - US-based late clinical-stage biopharmaceutical company Zavante Therapeutics, Inc. 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 company said.
The clinical trial is designed to assess the intrapulmonary penetration and pharmacokinetics of Zolyd to support future development as a treatment for US patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia infections.
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.
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. 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.
Zolyd, 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, 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, including acute pyelonephritis. The company plans to submit a New Drug Application to the FDA in early 2018.
Zavante Therapeutic is a privately-held, late clinical-stage biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients.