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Prana Provides Clinical Trials Update

Melbourne – 3 April, 2013; Prana Biotechnology (NASDAQ:PRAN; ASX:PBT) today reported on the progress of its lead development asset PBT2 in Phase II trials for Huntington disease and Alzheimer’s disease. Across the two trials approximately 37% have been dosed to 6 months or longer, twice the duration of the previous Phase II Alzheimer’s trial . 1,2 PBT2 has been well tolerated and both trials are on schedule with very pleasing retention rates and compliance. Each Independent Data Safety Monitoring Board for the two trials met at the end of March and recommended that each trial continue as planned without any protocol changes.

Prana’s PBT2 represents a novel and differentiated therapeutic action in the treatment of neurodegenerative diseases based on its specialized ability to prevent the toxic relationship between disease proteins and biological metals in the brain which otherwise can lead to protein amyloid formation. Moreover, the redistribution of such metals by PBT2 promotes neurotransmission and neuronal function.

Alzheimer’s disease Trial Update – the “IMAGINE” trial

In an earlier 12 week trial PBT2 both significantly changed amyloid levels in spinal fluid and improved the cognition of patients with Alzheimer’s disease.1,2 The IMAGINE trial, with 12 months of treatment, aims to establish PBT2 as a safe and effective treatment for Alzheimer’s disease. The following provides an update on the trial:

  • Last Patient recruited November 2012;
  • Last Patient to be Dosed November 2013;
  • Trial will be completed in December, 2013;
  • 7% of patients have completed 12 months of dosing, over 4 times longer than the previous longest exposure to PBT2;
  • 50% of patients have reached 26 weeks of dosing;
  • Data Safety Monitoring Board met on 27 March, 2013, with the recommendation to continue the trial without any changes to the original protocol.

The randomized, double-blind, placebo controlled trial has enrolled 41 patients with prodromal or mild Alzheimer’s disease in five sites in Melbourne, Australia. Brain Imaging is being used to measure PBT2’s effect on amyloid deposits in the brain (using PiB-PET scanning) and effects on increasing brain activity (FDG PET). Cognition effects are being measured by the Neuropsychological Test Battery (NTB).

The trial has received funding from the Alzheimer’s Drug Discovery Foundation (ADDF).

Howard Fillit, MD, the ADDF’s Executive Director commented, “PBT2 stands out as one of the few orally available agents with clinical trial evidence of cognitive benefit for Alzheimer’s patients. Success in this trial will demonstrate target engagement by PBT2 in the brain of people with Alzheimer’s disease, and accelerate the clinical development of PBT2 to patients.”

The protocol for the IMAGINE trial is available by clicking here.

​Huntington Disease Trial Update – the “Reach2HD” trial

The Reach2HD trial is a 6 month trial in 109 patients with early to mid-stage Huntington disease. The trial is being conducted across sites in the USA and Australia. The following provides an update on the trial:

Last Patient recruited December 2012;
Last Patient to be Dosed June, 2013;
Results anticipated October, 2013;
97% of patients have completed 12 weeks of dosing (equal to previous longest exposure of PBT2);
32% of patients have completed 6 months of dosing;
Data Safety Monitoring Board met on 28 March, 2013, with the recommendation to continue the trial without any changes to the original protocol.

Only one drug is marketed for Huntington disease and that is only for the relief of the severe motor or chorea symptoms. There are no approved treatments for the significant cognitive and behavioural components of the disease, which typically manifest before motor problems.

The protocol and site updates for the Reach2HD trial can be accessed by clicking here.

References

  1. Lannfelt et al. Lancet Neurology (2008) vol. 7, pp. 779-86; 
  2. Lannfelt et al. Erratum: Lancet Neurology (2009) vol. 8, pp. 981 

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