Prana Announces Safety Outcomes of Alzheimer’s IMAGINE Extension Trial
Prana Biotechnology has today announced the safety outcomes of the IMAGINE Extension study in patients with Alzheimer’s disease.
A 250mg dose of PBT2 was safe and well tolerated over a 2 year period. The independent Data Safety Monitoring Board did not identify any safety concerns related to PBT2.
The IMAGINE Extension Study allowed all 40 participants who completed the original 12 month IMAGINE trial to receive PBT2 for a further 12 months. In all, 33 out of the 40 eligible IMAGINE patients elected to continue onto the Extension study. It was an Open Label study, with all participants taking PBT2. A total of 27 patients completed the Extension Study.
Clinical and scientific experts are reviewing the effects of PBT2 taken for 2 years. Whilst there is no placebo group to compare to within the Extension Study, the experts are very interested in better understanding how treatment with PBT2 would differ from the anticipated outcome without treatment.
The safety data will form part of the package presented to the FDA as part of our goal to remove the Partial Clinical Hold on PBT2 in the US.
Prana will continue to work with the US Food and Drug Administration and other agencies to initiate a Phase 3 trial for PBT2 to treat Huntington disease. PBT2 for the treatment of Huntington disease was recently granted Orphan designation in Europe and was granted Orphan designation in the US in 2014.