Progressive Supranuclear Palsy Tx Granted Orphan Drug Status

C2N Diagnostics and AbbVie announced that the Food and Drug Administration (FDA) has granted orphan drug designation for C2N-8E12 (ABBV-8E12) for the treatment of progressive supranuclear palsy (PSP). C2N-8E12 is a recombinant humanized antibody targeting the tau protein found in neurofibrillary tangles in the brain of patients with tauopathies such as PSP and Alzheimer’s disease (AD).

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The Companies have also begun a Phase 1 randomized, double-blind, placebo-controlled, single ascending dose, multicenter study that will evaluate the safety, tolerability, and pharmacokinetics of C2N-8E12 in about 32 patients with PSP.

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