|C2N and Abbvie Inc. Confirm FDA Orphan Drug Designation Of C2n-8e12 For Treating Progressive Supranuclear Palsy|
|By David Fowler|
|Friday, 17 July 2015 16:00|
C2N Diagnostics and AbbVie Inc. (NYSE:ABBV) have confirmed that U.S. Food and Drug Administration has given approval for the investigational recombinant humanized anti-tau antibody.
An orphan drug designation, C2N-8E12 (ABBV-8E12), helps in treating progressive supranuclear palsy. The firms have also started Phase 1 clinical study of C2N-8E12 in patients having PSP. Joel Braunstein, M.D., chief executive officer, C2N Diagnostics, opined that FDA's orphan drug designation knows that there is lack of treatment options for patients suffering from PSP, which is a weakening neurological disease and is also a vital milestone in development of potential therapies.
Jim Sullivan, Ph.D., vice president, pharmaceutical discovery, AbbVie, opined that the firm is encouraged by preclinical data of anti-tau antibodies as well as looks to explore potential of the class of molecules.
C2N-8E12 is humanized antibody which aims at tau protein found in neurofibrillary tangles in brain of patients having tauopathies like PSP as well as Alzheimer's disease.
The Phase 1 study is randomized as well as placebo-controlled and multicenter study which would assess safety, tolerability as well as pharmacokinetics of C2N-8E12 in an estimated 32 subjects with PSP.
The Orphan Drug Designation program gives orphan status to biologics and drugs that are defined as the ones hoped for effective treatment, diagnosis as well as prevention of rare diseases which affect fewer than 200,000 people in the United States