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Investor Announcement, Huntington's Disease

Prana provides regulatory update for PBT2 for the treatment of Huntington disease

Prana Biotechnology Ltd (ASX PBT: NASDAQ PRAN) today announced that is has received further advice from the US Food and Drug Administration (FDA) on the steps necessary to remove the Partial Clinical Hold (PCH) on PBT2, including the requirement to undertake further non-clinical studies.

The PCH limits the dosage of PBT2 that can be used in clinical trials in the USA.  As part of Prana’s global clinical development strategy, the Company has now prioritised clinical development of PBT2 in Europe.  Later this month the Company is scheduled to meet with the Medical and Healthcare Regulatory Agency in London and the Medical Products Agency in Stockholm to receive formal scientific advice on how to best proceed to a Phase 3 trial in Huntington disease.

There is increasing non-clinical evidence that PBT2 protects brain cells from decay and death.  PBT2 has been shown to improve aspects of cognitive function in two clinical trials, one in Alzheimer’s disease and one in Huntington disease (HD).  These data supported the grant of Orphan drug designation for PBT2 in Europe for the treatment of HD.

Recently, Defined Health, a US based leading consultancy in therapeutic opportunity evaluation, has conducted research in Europe on Prana’s behalf and reported that cognitive decline in Huntington disease remains a significant unmet medical need, with no approved treatments.  Whilst pursuing this significant commercial opportunity to develop PBT2 for HD in Europe, Prana is in parallel undertaking a review of all available options to improve shareholder value.

Prana has commenced a process of reviewing other potentially suitable opportunities that may be highly attractive and have the ability to add shareholder value in the medium to longer term.  The Company currently has cash reserves of approximately A$30 million.  Further updates will be provided at Company’s the AGM to be held on Thursday 17th November 2016.