Biogen Inc. has submitted the final study protocol for the confirmatory Phase 4 ENVISION trial to the U.S. Food and Drug Administration (FDA) for review and approval. This is in line with the company's commitment to accelerate the timelines for the trial, including submitting the final study protocol to the FDA in March 2022, as previously announced. Biogen expects the first patient to enter screening in May 2022 and the trial's primary completion approximately four years after the study begins.

The confirmatory ENVISION trial is a requirement based on FDA's accelerated approval of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer's disease (Mild Cognitive Impairment due to Alzheimer's disease and mild Alzheimer's disease). The study, as previously announced, will be a global, placebo-controlled trial, aiming to enroll around 1,500 patients with early Alzheimer's disease and confirmation of amyloid beta pathology. The company has also reaffirmed the trial's goal of recruiting at least 18% of patients in the U.S. from Black/African American and Latino communities.

To increase participation among historically underrepresented patients, Biogen is leveraging multiple initiatives and working with several community groups, such as the National Minority Quality Forum and others who have expertise and a commitment in helping to overcome traditional enrollment barriers for diverse populations. These efforts are being addressed by three key strategies: Selecting sites with diverse staff, located in communities of color, with access to diverse patient populations; Supporting trial sites in identification, outreach, and engagement of underrepresented communities; and Engaging with community and patient organizations to increase Alzheimer's disease awareness, education, and access to research. The primary endpoint for the trial will be measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months, as announced in January 2022.

The trial will also include a planned long-term extension to collect treatment data for up to 48 months. Secondary endpoints include changes in Amyloid Positron Emission Tomography (PET) and Tau PET, as well as the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 13), Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Mild Cognitive Impairment Version (ADCS-ADL-MCI), Integrated Alzheimer's Disease Rating Scale (iADRS), Mini-Mental State Examination (MMSE) and Neuropsychiatric Inventory (NPI-10).