Updated on 24 July 2013
Mr Geoffrey Kempler, Prana's chairman and CEO, said, "Assuming we achieve the positive results we are hoping for in Reach2HD, we plan to meet with the US regulator, the Food and Drug Administration, and other regulatory agencies to discuss the next steps in the clinical development of PBT2 for the treatment of Huntington disease."
"We plan to discuss the design of the next trial and agree on a set of clinical outcomes that, when achieved, will allow us to submit a New Drug Application for approval to start to market PBT2 for Huntington disease," he added.
Huntington disease is a complex and severely debilitating genetic, neurodegenerative disease, for which there is no cure. The disease often affects young adults and, whilst associated with severe physical movement symptoms, progressively impacts the mind and emotions as well. The disease causes incapacitation and death about 15-25 years after onset. The disease affects over 30,000 people in the US and 70,000 worldwide.
The Huntington Study Group (HSG) collaborated with Prana to coordinate the Reach2HD trial across 20 sites in the USA and Australia.