AbbVie has commenced two Phase II clinical trials for the company’s investigational anti-tau antibody, ABBV-8E12. The drug will be evaluated in patients with early-stage Alzheimer’s disease, along with patients diagnosed with progressive supranuclear palsy (PSP).
PSP is a progressive neurodegenerative disorder which primarily affects those over the age of 60. Due to the similarity of symptoms – including balance problems and changes in movement – compared to Parkinson’s disease, PSP is often initially misdiagnosed.
Since no effective treatment exists for PSP, the US Food and Drug Administration (FDA) has granted Orphan Drug Designation and Fast Track Designation to ABBV-8E12. The European Medicines Agency (EMA) has granted orphan drug status to AbbVie’s investigational antibody for the treatment of PSP.
“We see potential in ABBV-8E12 and tau-focused approaches to progressive neurodegenerative diseases, such as early Alzheimer’s disease and PSP,” said Eric Karran, vice president, Foundational Neuroscience Center, AbbVie. “The initiation of the Phase 2 clinical trial programs and the FDA’s Fast Track Designation for PSP signify important steps forward in AbbVie’s ongoing commitment to investigating innovative scientific approaches with the hope of bringing new treatment options to patients.”
ABBV-8E12 is a humanized antibody designed to target the tau protein. While tau is thought to stabilize neuronal structures, its abnormal accumulation has been associated with a number of neurodegenerative disorders, including Alzheimer’s disease and PSP.
Pre-clinical and phase I studies showed positive results for ABBV-8E12, supporting the further development of the anti-tau antibody in PSP and Alzheimer’s disease. Phase I results for ABBV-8E12 were presented at last year’s Clinical Trials on Alzheimer’s Disease (CTAD) annual meeting.
The safety and efficacy of ABBV-8E12 will be assessed in 180 adult patients with PSP. The Phase II Alzheimer’s trial will enroll 400 patients with early-stage disease, to assess the antibody’s ability to slow disease progression.