Jul 17 2015
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.