Prana Biotechnology has announced the successful completion of a Phase I trial with its lead compound, PBT2, under development as a therapy for Alzheimer's disease.
The double blind, placebo-controlled single-dose-escalation study, conducted at a facility in Utrecht, the Netherlands, on 55 healthy male volunteers between the ages of 18 and 50, was designed to evaluate the safety, tolerability and pharmacokinetics of PBT2.
Data from the study showed PBT2 was well tolerated with little difference in the incidence of adverse events between those receiving PBT2 and those receiving the placebo. In addition, the pharmacokinetic analysis demonstrated that the drug exposure increased predictably and in a linear manner, both of which are excellent characteristics for a central nervous system drug. Concurrent pre-clinical findings also firmly indicated that PBT2 passes into the brain with more than 20 times greater efficiency than did its predecessor, PBT1.