Prana's Phase 2 trial data on Huntington Disease published in The Lancet Neurology

Nov 18 2014

Prana Biotechnology (ASX: PBT/NASDAQ:PRAN) has today announced the results of its Phase 2 trial in Huntington Disease, REACH2HD, has been published online in one of the world’s leading medical journals, The Lancet Neurology.

Prana announced in February 2014 the Company had successfully met its primary endpoint of safety and tolerability in the REACH2HD study, a double-blind, placebo-controlled study conducted by Prana and the Huntington Study Group at research sites in the United States and Australia. The study enrolled 109 individuals with Huntington disease who were randomly assigned to receive daily doses of either PBT2 250mg, PBT2 100mg, or placebo for 26 weeks.

The paper was authored by investigators from the Huntington Study Group led by Dr Ray Dorsey, Professor of Neurology at the University of Rochester and the Principal Investigator on the trial. The paper is accompanied by an editorial in The Lancet Neurology. The results support the view the findings of the REACH2HD Study warrant further investigation in a large clinical study powered to measure efficacy.

Dr Dorsey said:

Publication in The Lancet Neurology reflects the outstanding contribution of the investigators and participants in the study, highlights the importance of the study, and serves as a basis for planning future studies of PBT2 for the treatment of Huntington disease.

Geoffrey Kempler, Executive Chairman of Prana Biotechnology, said the next steps for the commercialisation program of PBT2 for Huntington disease was the End of Phase 2 meeting with the US Food and Drug Administration (FDA). Prana is currently finalising the dossier to submit to the FDA for this meeting.

“The Lancet publication supports our commitment to take the next steps in the commercial pathway towards developing PBT2 as a treatment for Huntington disease,” Mr Kempler said.

“Publication of the Reach2HD trial follows the recent granting of Orphan Drug designation by the FDA for PBT2 for Huntington Disease.”