Prana Announces Results Of Phase 2 Imagine Trial Of PBT2 In Alzheimer's Disease

(RTTNews) - Prana Biotechnology (PRAN) announced the top line results of the 12-month Phase II Imaging trial in Alzheimer's Disease, based on draft results. Prana stated that its PBT2 did not meet its primary endpoint of a statistically significant reduction in the levels of beta-amyloid plaques in the brains of prodromal/mild Alzheimer's disease patients, as measured using PiB-PET Standardized Uptake Value Ratio or SUVR.

Whilst there was a reduction in the overall levels of the PiB PET signal in patients treated with PBT2, the results were confounded by an atypical reduction of levels of the PiB PET signal in the placebo group as well.

No improvement was observed on the secondary endpoints of brain metabolic activity, cognition and function; however there was a trend towards preserving hippocampal brain volume in the PBT2 group.

Specifically, there was less atrophy in those patients treated with PBT2 relative to placebo, 2.6% and 4.0%, respectively. This is consistent with published measures of atrophy in AD patients versus healthy controls2 of 4.7% and 1.4%, respectively.

The company stated that it is tracking measures of brain volume and cognition in the current 12 month extension study that will be completed at the end of the year. Further analysis of the results is ongoing.

PBT2 was shown to be safe and very well tolerated over the 52 weeks. The adverse event profile was equivalent between placebo and treated groups. Forty of the 42 enrolled participants (95%) completed the 52 week treatment period.

Prana said it has a cash position of A$25.4 million as at 31 March 2014.