Prana Meets Primary Endpoint In Phase 2 REACH2HD Trial Of PBT2 - Quick Facts

(RTTNews) - Prana Biotechnology Ltd. (PRAN) said its Phase 2 REACH2HD study investigating PBT2 as a treatment for Huntington disease met its primary safety endpoint and achieved statistically significant improvement in a measure of executive function, which comprised part of the study's main efficacy outcome. Prana intends to advance PBT2 into a confirmatory Phase 3 trial that could allow PBT2 to be approved to treat Huntington disease.

Ray Dorsey, Professor of Neurology at the University of Rochester and the Principal Investigator on the trial said: "We are very pleased that the results of the Reach2HD study have shown that PBT2 is well tolerated and generally safe over six months in individuals with early to mid-stage Huntington disease."

Furthermore, the results indicated a significant benefit on cognition that is consistent with the earlier trial in Alzheimer's disease and is accompanied by an encouraging finding in functional capacity. In this study, PBT2 was safe and well tolerated. Ninety-five percent of participants completed the study on their assigned dose.

Reach2HD is a double-blind, placebo-controlled study was conducted by the Huntington Study Group at research sites in the United States and Australia. The trial 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.