(MENAFN - ProactiveInvestors - Australia) Prana Biotechnology (ASX: PBT) has completed the six month treatment of the first patient in a phase IIa trial of the company's lead drug candidate, PBT2, in patients with early to mid-stage Huntington disease.
Importantly, no patients have withdrawn from the trial for any safety or other reasons.
The Reach2HD trial is a 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.
Enrolment began in April 2012 following approval from the U.S. Food and Drug Administration to conduct the trial across sites in the U.S. and Australia.
All 20 Reach2HD sites are open and recruiting.
Based on current recruitment activity, it is expected that over 80% 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 and reporting of results in the second half of 2013.
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.
PBT2 has a unique therapeutic action because of its specialised ability to prevent the toxic relationship between disease proteins and biological metals in the brain.
Of special relevance to Huntington disease, PBT2 has shown in animal modelling that it can reduce the aggregation of a mutant form of the Huntington protein that is associated with the disease, improve motor function, preserve neuronal tissue and significantly improve life expectancy.
PBT2 has also demonstrated a significant ability to improve cognitive executive function " "thinking ability" in a phase IIa study in Alzheimer's disease.
Currently there is only one marketed drug for Huntington disease, with limited utility, and notably there are no drugs either available or in development that have established clinical evidence for treating the cognitive decline associated with Huntington disease.
Prana recently raised A6 million to support the company's two ongoing Phase 2 clinical trials, the IMAGINE trial and Reach2HD trial.
The 12-month IMAGINE trial aims to establish PBT2 as a safe and effective treatment for Alzheimer's disease.