Prana completes PBT2 dosing in IMAGINE Alzheimer’s Disease clinical trial
95% patient retention level achieved in IMAGINE trial
MELBOURNE, December 9, 2013: Prana Biotechnology (ASX:PBT; NASDAQ:PRAN), a developer of best-in-class treatments for neurodegenerative disease, today announced the completion of the treatment phase of its IMAGINE Alzheimer’s Disease (AD) clinical trial.
There were 42 patients with prodromal or mild AD enrolled in the Phase II double-blind placebo-controlled clinical trial of Prana’s novel drug, PBT2. A total of 40 patients completed the planned 12 months of treatment with PBT2, or placebo, bringing the treatment phase of the trial to a close.
The IMAGINE trial received funding from the New York based Alzheimer’s Drug Discovery Foundation (ADDF). ADDF’s Executive Director Howard Fillit, MD, said the results were now keenly anticipated. “At the time of initiating the trial, we noted that PBT2 stood out as one of the few remaining orally available agents with clinical trial evidence of cognitive benefit for Alzheimer’s patients,” Dr Fillit said. “Since then the relevance of this trial and its design has only increased, in light of the changing competitive and regulatory landscape for Alzheimer’s drugs in development.” “The ADDF is proud to have supported this PBT2 trial design that reflects the US Food and Drug Administration’s new guidelines encouraging companies to look at treating patients earlier in the disease process.” The primary outcome of IMAGINE is the effect of 12 months of treatment with a daily oral dose of 250mg of PBT2 on beta amyloid deposits in the brain. Other outcomes include the effects of PBT2 on increasing brain activity (F-FDG PET), brain volume (MRI) and cognition, measured by a Neuropsychological Test Battery (NTB). The IMAGINE protocol can be accessed here*.
To qualify for participation in the trial, patients completed a PiB-PET brain scan to confirm a level of beta amyloid deposit consistent with prodromal or early disease. Only two patients withdrew during the trial representing a trial retention rate of 95%.
An independent Data Safety Advisory Board met five times during the course of the trial and on no occasion made any recommendations to vary the original trial protocol.
The data compilation and statistical analysis will commence shortly after the last few patients complete their follow up visit, with results expected in March 2014. Currently all available treatments for AD are approved to provide some degree of symptomatic relief. None change the course of the disease and the eventual decline in patient’s cognition and health. The IMAGINE study design aims to demonstrate PBT2’s potential as an effective disease modifying treatment available to patients.