Biogen (BIIB) to Present Data from ADUHELM and Alzheimer’s Disease Portfolio at 2021 Alzheimer’s Association International Conference
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Biogen Inc. (Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021. The company’s contributions to AAIC will include several presentations highlighting data on ADUHELM™ (aducanumab-avwa) injection 100 mg/mL solution, which was recently granted accelerated approval by the U.S. Food and Drug Administration (FDA) as a treatment for Alzheimer’s disease, as well as its broader Alzheimer’s disease portfolio and research in the field.
ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
Data presentations on ADUHELM will include presentations on multiple topics, including results of an analysis of the PRIME, EMERGE and ENGAGE studies on the correlation between reductions in biomarkers of Alzheimer’s disease and clinical decline after treatment with ADUHELM. The company’s contributions to the congress include four presentations on ADUHELM data and a total of 11 abstracts.
The company will also lead a late-breaking presentation on the design of the real-world observational Phase 4 study in Alzheimer’s disease, a prospective registry of ADUHELM, called International Collaboration for Real-World Evidence in Alzheimer’s Disease (ICARE AD-US). ICARE AD-US is focused on collecting real-world, long-term effectiveness and safety data on ADUHELM.
Biogen’s commitment to generate new data about ADUHELM includes three components: the ICARE AD study, the ongoing redosing study, EMBARK, for eligible patients previously enrolled in aducanumab trials, and the upcoming confirmatory, controlled Phase 4 trial that is part of the post-marketing requirement in connection with ADUHELM’s accelerated approval.
Posters and presentations will be available for 30 days on the AAIC conference website. Biogen will also post the aducanumab and BIIB080 posters and presentations on the investors section of its website at investors.biogen.com at the times indicated below.
Biogen Oral and Poster Presentations:
- Oral presentation: ICARE AD-US: Design of a Prospective, Single-arm, Multicenter, Noninterventional Real-world Study of Aducanumab in United States: July 29, 10:00 am to 11:15 am ET (#57522). This presentation will be available on Biogen’s website concurrent with the presentation.
- Poster presentation: Reduction in Biomarkers of Alzheimer’s Disease Pathophysiology Following Treatment with Aducanumab Were Associated with Slowing Clinical Decline – virtual poster #57499. This poster will be available on Biogen’s website on July 26 at 10:00 am ET.
- Poster presentation: Subgroup Analyses of the Amyloid PET Substudies from EMERGE and ENGAGE, Phase 3 Clinical Trials Evaluating Aducanumab in Patients with Early Alzheimer’s Disease– virtual poster #57496. This poster will be available on Biogen’s website on July 26 at 10:00 am ET.
- Poster presentation: Considerations for the Real-World Management of ARIA from the Aducanumab Phase 3 Studies EMERGE and ENGAGE – virtual poster #57498. This poster will be available on Biogen’s website on July 26 at 10:00 am ET.
- Poster presentation: Item-level Analysis of Clinical Measures in Patients with Early Symptomatic Alzheimer’s Disease Following Treatment with High-Dose Aducanumab in the Phase 3 Study EMERGE – virtual poster #57619. This poster will be available on Biogen’s website on July 26 at 10:00 am ET.
- Poster presentation: Ten-minute Cognitive Screening Tool for Mild Cognitive Impairment and Prediction of Pathological ß-amyloid - virtual poster #54618.
- Oral presentation: Development of a Site Readiness Framework to Improve Health System Preparedness for Potential New Alzheimer’s Disease Therapies –July 29, 3:00 pm – 4:15 pm ET (#57672).
- Oral presentation: Drivers and Barriers to Participation of Black and Hispanic Groups in Alzheimer’s Disease Clinical Trials: a Qualitative Study – Developing Topics 1 - July 29, 10:00 am – 11:15 am ET (#57652).
- Poster presentation: Baseline Biomarker (Tau PET) Characteristics from TANGO: A Phase 2 Trial of Gosuranemab (BIIB092) in Early Alzheimer’s Disease – virtual poster #54952.
- Poster presentation: Results of the First-in-Human, Randomized, Double-Blind, Placebo-Controlled Phase 1b Study of Lumbar Intrathecal Bolus Administrations of Antisense Oligonucleotide (ISIS 814907; BIIB080) Targeting Tau mRNA in Patients with Mild Alzheimer’s Disease– virtual poster #51871. This poster will be available on Biogen’s website on July 26 at 10:00 am ET.
- Poster presentation: Clinical performance of the b-amyloid (1-42/1-40) ratio determined from automated Lumipulse G1200 cerebrospinal fluid Ab1-42 and Ab1-40 assays, assessed by concordance with PET imaging status– virtual poster #57725.
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