Prana to begin Ph IIa trials of PBT2 in AD

Australian firm Prana Biotechnology, a specialist developer of treatments for age-related degenerative disorders, says that it will move PBT2, its developmental Alzheimer's disease drug, into Phase IIa clinical trials by the fourth quarter of the year. In a previous Phase I assessment and non-clinical studies, the compound displayed the ability to prevent the formation of toxic oligomers of the a-beta proteins that are characteristic of AD.

The program, which will be conducted at several research centers in Sweden, will comprise a full evaluation of the agent's safety and tolerability in addition to assessing its efficacy and mode of action. The study itself will be a randomized, double-blind, placebo controlled examination which will run for a duration of three months. Patients will receive one of three dosage strengths of the compound or placebo, with the drug's effects being measured by assessment of multiple biomarkers in the cerebrospinal fluid and blood.

The company added that it would use the resulting data, together with the findings of a planned larger-scale assessment, to capitalize on new European Medicines Agency regulations which allow Conditional Marketing Authorization of treatments for life-threatening or debilitating conditions where alternative therapeutic regimen are not available.