Updated on 15 November 2012
All twenty Reach2HD sites are open and recruiting
Singapore: Melbourne-based Prana Biotechnology released an update on the Huntington Disease trial. The company reported the progress in the Reach2HD trial at the Huntington Study Group Annual Conference held in Seattle, US.
The Reach2HD trial is a phase IIa, six-month trial in 100 patients with early to mid-stage Huntington disease that are treated with one of two doses of PBT2 or placebo. Enrollment commenced in April 2012 following approval from the FDA to conduct the trial across sites in the US and Australia. All twenty Reach2HD sites are open and recruiting. Based on current recruitment activity, it is expected that over 80 percent of patients will be in dosing by the end of this month in line with Prana's recruitment completion target at the end of the year.
Of special relevance to Huntington disease, PBT2 has been shown in animal modeling that it can reduce the aggregation of a mutant form of the Huntingtin protein that is associated with the disease, improve motor function, preserve neuronal tissue and significantly improve life expectancy. Moreover
PBT2 has demonstrated a significant ability to improve cognitive executive function (thinking ability) in a phase IIa study in Alzheimer's disease. Based on the breadth of pre-clinical and clinical data to date, Prana's Reach2HD trial has been designed to investigate safety and tolerability of PBT2 in Huntington disease patients and to measure potential cognitive, functional and motor benefits in patients and also explore mechanistic biomarker readouts.