Date: 2017-01-25
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: AbbVie
Product: ABBV-8E12/C2N-8E12
Action
mechanism: monoclonal antibody. ABBV-8E12/C2N-8E12 is a humanized antibody targeting the tau protein found in neurofibrillary tangles in the brain of patients with tauopathies such as progressive supranuclear palsy and Alzheimer's disease. On March 19, 2015, AbbVie and C2N Diagnostics have entered into an exclusive worldwide license agreement to develop and commercialize a portfolio of anti-tau antibodies for the treatment of Alzheimer's Disease and other neurological disorders. In recognition of the lack of treatment options available to patients with PSP, the FDA granted Fast Track Designation to ABBV-8E12. The FDA and European Medicines Agency (EMA) also granted Orphan Drug Designations to ABBV-8E12 for progressive supranuclear palsy.
Disease: progressive supranuclear palsy
Therapeutic area: Rare diseases - Neurodegenerative diseases - Neurological diseases
Country: USA
Trial
details: The purpose of this study is to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP). (NCT02985879)
Latest
news: * On January 25, 2017, AbbVie announced the start of a Phase 2 clinical trial program to evaluate ABBV-8E12, an investigational anti-tau antibody, in patients with progressive supranuclear palsy (PSP). After consultation with the FDA and EMA, AbbVie is beginning the Phase 2 clinical trial programs following completion of pre-clinical studies and a Phase 1 study in patients with PSP, which supported the further development of ABBV-8E12 in PSP and early Alzheimer's disease. Positive results from the Phase 1 study in PSP were recently released at the Clinical Trials on Alzheimer's Disease (CTAD) annual meeting in December 2016. The Phase 2 study in PSP will evaluate 180 adults and assess the efficacy and safety of ABBV-8E12 to slow disease progression.
