The study is expected to complete mid-2019, however Alterity has been invited to present interim data from the initial four single dose cohorts and the initial three multiple dose cohorts. The data being released indicate that PBT434 was well tolerated with adverse event rates comparable to placebo and dose dependent systemic exposure following oral administration.
Importantly, the results indicate that PBT434 not only crosses the blood brain barrier in humans, confirming previous observations in animal studies, but that clinically tested doses achieve concentrations in the brain that exceed those associated with efficacy in animal models of disease.
No serious adverse events were reported and no subject discontinued dosing with PBT434 due to adverse events.