Prana Biotechnology Receives FDA Approval to Commence Clinical Trial for Huntington's Disease Drug; Shares Gain Nearly 9%
Prana Biotechnology Limited ( PRAN ) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to start recruiting patients for the company's first clinical trial using the experimental drug PBT2 in patients with Huntington's Disease ( HD ).
The trial will be randomised, double-blind, placebo-controlled and will enroll 100 patients with early to mid-stage Huntington's Disease. The primary objective is to determine the safety and tolerability of two dose levels of PBT2 when administered orally once daily over 26 weeks in patients with HD.
Shares are up 8.90% to $1.59, but off a day high $1.75.