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Zavante Therapeutics partners with NIAID to assess ZOLYD for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

M2 PHARMA-September 11, 2017-Zavante Therapeutics partners with NIAID to assess ZOLYD for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia

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Biopharmaceutical company Zavante Therapeutics Inc revealed on Thursday the launch of a Clinical Trial Agreement to evaluate its investigational antibiotic ZOLYD (fosfomycin for injection, also known as ZTI-01) for bacterial pneumonia in partnership with the National Institute of Allergy and Infectious Disease (NIAID).

The company said the clinical trial is designed to assess the intrapulmonary penetration and pharmacokinetics of ZOLYD to support future development for US patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) infections, with a combined mortality rate of up to 33%.

In conjunction, the US FDA has granted Fast Track and Qualified Infectious Disease Product (QIDP) designations to ZOLYD for both indications, HABP and VABP.

According to the partnership, 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.

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). Zavante will supply the investigational product that will be tested in this trial.

Under the trial, the companies will measure ZOLYD's pulmonary penetration by assessing drug concentrations in the lining of subjects' bronchial pathways. The NIAID-supported trial will provide additional data regarding the safety and tolerability of a contemporary dosing regimen (six grams every eight hours) to support further evaluations in the intended patient populations.

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Publication:M2 Pharma
Date:Sep 11, 2017
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