The phase I dose escalation study, was conducted in Utrecht, The Netherlands, on 32 healthy male and female volunteers between the ages of 45 and 75. The study was designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of PBT2 administered once daily for seven days.
Initial results indicate that multiple doses of PBT2 are generally well tolerated by both male and female subjects in the critical target age group for Alzheimer’s disease treatment.
The company said that the chronic toxicology studies and manufacturing development required for phase II clinical studies are ongoing.
“The results of the human safety trials reinforce our belief that PBT2, Prana’s lead MPAC compound, possesses the attributes to allow it to be the first drug on the market that targets the beta-amyloid protein to treat Alzheimer’s disease,” said Geoffrey Kempler, executive chairman and CEO.