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news.AbbVie and C2N Diagnostics have received orphan drug designation from the US Food and Drug Administration (FDA) for their investigational recombinant humanized anti-tau antibody, C2N-8E12 (ABBV-8E12) to treat progressive supranuclear palsy (PSP), a progressive neurodegenerative disorder.
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C2N-8E12 is a humanized antibody that targets the tau protein found in neurofibrillary tangles in the brain of patients with tauopathies such as PSP and Alzheimer’s disease (AD).
C2N Diagnostics chief executive officer Joel Braunstein said: "The FDA’s orphan drug designation recognizes the lack of treatment options for patients with PSP, a debilitating neurological disease, and is an important milestone in the development of potential therapies."
The companies have also initiated a randomized, double-blind, placebo-controlled, single ascending dose, multicenter Phase I clinical trial of C2N-8E12 in patients with PSP.
The trial will evaluate the safety, tolerability and pharmacokinetics of C2N-8E12 in an estimated 32 subjects with PSP.
AbbVie pharmaceutical discovery vice-president Jim Sullivan said: "We are encouraged by the preclinical data of anti-tau antibodies and are committed to exploring the potential of this class of molecules."