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Prana Alzheimer's disease Development Program update
Date:7/17/2014

over time in that participant (p=0.035), whereas there was no such correlation in the placebo group.

Prof Masters further investigated the response of participants with baseline amyloid burden levels above and below the mean for the IMAGINE cohort (SUVR of 2.5). He showed that in the subgroup of PBT2 treated participants with a baseline of SUVR above 2.5, there was a significant decrease in amyloid burden that was not observed in participants on placebo nor PBT2 participants with a SUVR less than 2.5. In summary, whilst the utility of PiB in small trials may be questioned, it was interesting to note the impact of baseline SUVR amyloid burden level on the response of a cohort, for future trial design.

Separately, Prana has confirmed the top line finding that there is a very promising trend towards the preservation of brain volume (as measured by MRI) in PBT2 treated patients compared to placebo patients.

Mechanism of action of PBT2 in AD 
PBT2 prevents formation and toxicity of pathological ABeta species (primarily soluble oligomers) and promotes their clearance. In Professor Masters' presentation he proposes the observed effect upon amyloid burden is due to increased clearance by PBT2 of pools of PIB-detectable non-fibrillar soluble and membrane bound ABeta.
Through its metal chaperone activity, PBT2 activates intracellular signalling pathways which promote neuronal health and plasticity and suppress pathobiological processes including the abnormal phosphorylation of tau. The trend towards reduced hippocampal atrophy seen in the PBT2 treatment group mirrors the Company's preclinical observations and reinforces a similar trend observed in the Reach2HD Huntington's disease study.

"Understanding the limitations of a small trial, the atypical placebo group response, previous clinical findings (the EURO trial), the strong body of peer reviewed science, along with the sub-analyses of IMAGINE, the company remains enthusiastic abo
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