Prana Accelerates PBT2 Commercial Development
Product News Apr 22, 2011
Prana Biotechnology has announced its business strategy to accelerate development of its lead asset, PBT2. The strategy, that now includes Huntington's Disease, should enable Prana to target market approval for PBT2 several years sooner than previously planned and at considerably less cost.
The company has designed a Phase II placebo controlled double blind study in 100 mild Huntington's Disease (HD) patients, in Australia and the US, treated over 6 months.
This trial will be conducted in parallel to the previously announced 12 month Phase II brain imaging study in 40 mild Alzheimer's Disease (AD) patients, in Australia, supported by the US based Alzheimer's Drug Discovery Foundation. Recruitment for both trials is planned to commence in the second half of the year.
"We are excited by this strategy because from a commercial perspective these diseases are very complementary. From our earlier Alzheimer's trial we showed that PBT2 significantly improves cognitive executive function. This is very relevant to Huntington's Disease given that these patients also suffer cognitive decline, for which there is no marketed treatment available.
Success in the trial that we have announced today will position PBT2 as a frontrunner in the treatment of Huntington's Disease. We believe that PBT2 can bring the same cognitive benefits to Huntington's Disease patients that it did to Alzheimer's Disease patients," commented Mr. Geoffrey Kempler, Prana's Executive Chairman.
"Because Huntington's Disease is a relatively uncommon disease, it is classed as an 'orphan indication' by regulators, a status that typically confers accelerated regulatory review by authorities and faster approval to market. That also means the cost will be considerably less," added Mr. Kempler.