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news.The US FDA has granted approval to commence Prana Biotechnology's first clinical trial using PBT2 in patients with Huntington's Disease (HD).
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According to the company, its Investigational New Drug Application (IND) is now open for a Phase 2 study that follows a review of PBT2 data by the FDA and reflects a favourable analysis from the FDA to support the study of PBT2 in Huntington’s Disease patients.
The randomised, double-blind, placebo-controlled trial named Reach2HD will enrol 100 patients with early to mid-stage Huntington’s Disease.
The company has appointed a Huntington Study Group (HSG) to coordinate the trial.
The group said that PBT2 has the potential to bring real benefit to Huntington’s Disease patients and the PBT2 trial in Alzheimer’s disease yielded promising data.