C2N-8E12 (ABBV-8E12) gets orphan drug designation from FDA for PSP treatment

C₂N Diagnostics and AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted their investigational recombinant humanized anti-tau antibody, C₂N-8E12 (ABBV-8E12), an orphan drug designation for the treatment of progressive supranuclear palsy (PSP). The companies also have begun a Phase 1 clinical study of C₂N-8E12 in patients with PSP.

"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," stated Joel Braunstein, M.D., chief executive officer, C₂N Diagnostics.

"We are encouraged by the preclinical data of anti-tau antibodies and are committed to exploring the potential of this class of molecules," said Jim Sullivan, Ph.D., vice president, pharmaceutical discovery, AbbVie.

C₂N-8E12 is a 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). The Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose, multicenter study that will evaluate the safety, tolerability and pharmacokinetics of C₂N-8E12 in an estimated 32 subjects with PSP (https://clinicaltrials.gov/ct2/show/NCT02494024).

SOURCE AbbVie Inc.