FDA End of Phase 2 Status Update
MELBOURNE, Friday, February 13th, 2015: Prana Biotechnology (ASX: PBT/NASDAQ:PRAN) has today announced the status of its End of Phase 2 discussions with the US Food and Drug Administration (FDA).
At the End of Phase 2 meeting for its Reach2HD clinical trial, and following subsequent correspondence, Prana presented its plans and information package to initiate a Phase 3 trial in Huntington Disease.
Upon review, the FDA has issued a Partial Clinical Hold letter based on non-clinical (animal) findings which currently limits the dose of PBT2 that can be given to patients with Huntington disease. Under Prana’s open Investigational New Drug application, Prana is able to continue clinical trials but at a dose that is not considered clinically relevant by the Company.
The FDA has provided Prana with options to remove the Partial Clinical Hold. To support moving forward with clinical trials of PBT2 at a clinically relevant dosage in humans, Prana would conduct additional animal neurotoxicity studies or identify a strategy for safely using a clinically relevant dosage in humans in the planned Phase 3 trial in Huntington disease. The FDA has not raised any concerns about PBT2 safety data in human trials conducted to date.
The company is continuing discussions with the FDA in addressing these issues.