First patient enrolled in Phase 3 study of aducanumab in Alzheimer’s
Posted: 8 September 2015 |
Biogen’s Phase 3 programme includes two global studies designed to evaluate the efficacy and safety of aducanumab in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease…
The first patient has been enrolled in the Phase 3 clinical programme for Biogen’s investigational treatment aducanumab.
Aducanumab is a human recombinant monoclonal antibody (mAb) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline.
Aducanumab is thought to target aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients. Based on preclinical and interim Phase 1b data, treatment with aducanumab has been shown to reduce amyloid plaque levels.
The Phase 3 programme includes two global, placebo-controlled studies named ENGAGE and EMERGE, which are designed to evaluate the efficacy and safety of aducanumab in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease.
Biogen have accelerated its aducanumab clinical programme
“Since the initial readout of our Phase 1b study, we have accelerated our aducanumab clinical programme so that we can more fully characterise and confirm the benefit-risk profile of this investigational treatment for Alzheimer’s disease,” said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen. “Understanding the urgency to find effective treatments for this devastating disease, we are excited that we have enrolled our first patient in the Phase 3 programme and we continue to work with our colleagues around the world to advance the study of aducanumab.”
ENGAGE and EMERGE will assess the efficacy and safety of aducanumab in approximately 2,700 people with early Alzheimer’s disease. The studies are identical in design and eligibility criteria. Each study will be conducted in more than 20 countries in North America, Europe and Asia.
Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. The enrolment of the first patient in the Phase 3 programme for aducanumab triggers a $60 million milestone payment to Neurimmune in the third quarter of 2015.