Phase I data for OZ439 is published demonstrating its safety and potential as a one-dose cure
Published in the British Journal of Clinical Pharmacology, the results of the first trial of OZ439 in healthy human volunteers demonstrate it to be well tolerated in doses up to 1600 mg. The concentration of drug achieved in the blood with these doses should be sufficient to kill malaria parasites for up to 96 hours – considerably longer than that of currently available artemisinin-based antimalarials. These data therefore support the potential of OZ439 as a one-dose cure.
On the basis of this phase I data, the phase II trial to evaluate OZ439’s safety and efficacy in malaria patients has been initiated. Preliminary results with a single dose have confirmed that OZ439 maintains similar concentrations in malaria patients to those observed in the phase I study. Additionally, its efficacy appears similar to that of artemisinin against both P. falciparum and P. vivax.
OZ439 was discovered in partnership with three academic institutes: University of Nebraska Medical Center, USA, Monash University, Australia, and the Swiss Tropical and Public Health Institute with the support of MMV. Today, MMV is solely responsible for the clinical development of this exciting new molecule.
View the open-access article: First-in-man safety and pharmacokinetics of synthetic ozonide OZ439 demonstrates an improved exposure profile relative to other peroxide antimalarials