Biogen + Eisai initiates Phase III studies -ENGAGE and EMERGE for aducanumab to treat early Alzheimers Disease

Biogen announced that the first patient has been enrolled in the Phase III clinical program for its investigational treatment aducanumab. The Phase III program 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.

ENGAGE and EMERGE will assess the efficacy and safety of aducanumab in approximately 2,700 people with early AD. 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. For more information about the Phase III studies, including information about participating centers visit www.aducanumabclinicaltrials.com or clinicaltrials.gov (NCT02477800 or NCT02484547).

Comment: Biogen is not conducting Phase II trials and now moves directly into Phase III based on interim Phase Ib results (PRIME study) that show a dose-dependent reduction in amyloid-beta buildup in the brain and cognition gains for treated patients.