Prana: 250 Mg Dose Of PBT2 Safe, Well Tolerated In 2 Years Alzheimer's Study

(RTTNews) - Prana Biotechnology(PRAN) announced the safety outcomes of the IMAGINE Extension study in patients with Alzheimer's disease. A 250 mg 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, the experts are 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 the company's goal to remove the Partial Clinical Hold on PBT2 in the U.S.

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 U.S. in 2014.