- Late breaker will show ADUHELM™ effect on plasma pTau181 reduction, and its correlation with amyloid beta and slowing cognitive and functional decline.
- Additional phase 3b late breaker data will shed light on clinical decline and amyloid beta plaque levels after patients stopped treatment.
- With data from the largest clinical trial dataset in early Alzheimer’s disease, Biogen contributes 11 presentations to CTAD, supporting robust scientific insights and dialogue.
A late breaking presentation will highlight important new data from over 7,000 plasma samples from the ADUHELM Phase 3 trials that, for the first time, examines the effect of ADUHELM on plasma phosphorylated tau181 (p-Tau181) and its correlation to amyloid beta plaques and disease progression, as measured by clinical decline endpoints, in patients with early Alzheimer’s disease. The accumulation of amyloid beta plaques and tangles of tau proteins in brain cells are the two defining pathologies of Alzheimer’s disease.
“We collected an unprecedented sample size—approximately 7,000 plasma samples from more than 1,800 patients—to provide robust answers to questions about the correlation between plasma pTau reduction, amyloid beta plaque levels and clinical decline in Alzheimer’s disease. We are eager to engage the scientific community with the findings from this comprehensive dataset,” said
The data will be discussed at the virtual oral presentation and roundtable: “Dose and time dependent changes in plasma ptau181 in patients treated with aducanumab in the ENGAGE and EMERGE trials,” on
Biogen will also present data from over 1,800 patients that were screened for the EMBARK re-dosing trial with ADUHELM, to shed light on the impact of stopping treatment in clinical trials. Patients who were enrolled in the ADUHELM trials when they were discontinued in 2019 later re-enrolled in the EMBARK trial, after a lengthy off-treatment period of an average of 1.7 years. Some of these patients had been on treatment for more than 4 years in the PRIME Phase 1b long-term extension, as well as for up to 18 months in the Phase 3 trials, EMERGE and ENGAGE. Disease progression and amyloid beta plaque levels during this extended discontinuation of Alzheimer’s disease treatment will be examined in the Virtual Oral Presentation, “Baseline EMBARK data from EMERGE, ENGAGE, and PRIME participants in the EMBARK re-dosing study,” on
In addition, a poster titled, “Urgency to treat before it’s too late: Daily transitions to moderate AD dementia in the US and Europe,” will examine how many people are estimated to progress daily from mild cognitive impairment due to Alzheimer's disease to mild Alzheimer’s disease, and from mild Alzheimer’s disease to moderate Alzheimer's disease, pointing to the urgency for earlier detection, diagnosis and treatment.
Abstract details:
- ADUHELM
- Late Breaking Virtual Oral Presentation: Baseline EMBARK data from EMERGE, ENGAGE, and PRIME participants in the EMBARK re-dosing study (Cohen S; #LBR2) – Available virtually starting on
Tuesday, November 9 ,8:00 a.m. EST - Late Breaking Virtual Oral Presentation: Defining a standardized MRI acquisition protocol to be proposed to ICARE AD-US sites for baseline and ARIA monitoring (Benzinger T; #LBR4) – Available virtually starting on
Tuesday, November 9 ,8:00 a.m. EST - Late Breaking Virtual Oral Presentation: Dose and time dependent changes in plasma ptau181 in patients treated with aducanumab in the ENGAGE and EMERGE trials (Hanson O, #Late Breaking Readout Roundtable 8) –
Thursday, November 11 ,5:10 p.m. EST
- Late Breaking Virtual Oral Presentation: Baseline EMBARK data from EMERGE, ENGAGE, and PRIME participants in the EMBARK re-dosing study (Cohen S; #LBR2) – Available virtually starting on
- BIIB092
- Late-Breaking Virtual Oral Presentation: Top-line results from TANGO, a Phase 2 study of gosuranemab in participants with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease (Shulman; #LBR5, Shulman) – Available virtually starting on
Tuesday, November 9 ,8:00 a.m. EST
- Late-Breaking Virtual Oral Presentation: Top-line results from TANGO, a Phase 2 study of gosuranemab in participants with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease (Shulman; #LBR5, Shulman) – Available virtually starting on
- BIIB076
- Virtual Oral Presentation: Results of A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB076 in
Healthy Volunteers and Subjects With Alzheimer’s Disease (Ratti E; #ROC16) – Available virtually starting onTuesday, November 9 ,8:00 a.m. EST
- Virtual Oral Presentation: Results of A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB076 in
- General Alzheimer’s Disease
- Poster Presentation: Urgency to treat before it’s too late: Daily transitions to moderate AD dementia in the US and
Europe (Maserejian N; #LP23) –Wednesday, November 10 , throughFriday, November 12 . - Poster Presentation: Distribution and baseline characteristics of participants with rapid progressing Alzheimer’s Disease as measured by CDR-SB over 78 weeks in the National Alzheimer’s Coordinating Center (NACC) (Gillis C; #P63) -
Wednesday, November 10 , throughFriday, November 12 . - Poster Presentation: Updated
U.S. prevalence estimates accounting for racial and ethnic diversity for trials and therapies targeting mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia (Maserejian N; #LP22) -Wednesday, November 10 , throughFriday, November 12 . - Poster Presentation: Sigmoid methodology allows early prediction of cognitive decline towards Alzheimer’s disease across several cognitive domains (Doecke J; #RP25) -
Wednesday, November 10 , throughFriday, November 12 . - Poster Presentation: Global prevalence of Alzheimer’s disease across disease stages (Gustavsson A; #RP36) -
Wednesday, November 10 , throughFriday, November 12 .
- Poster Presentation: Urgency to treat before it’s too late: Daily transitions to moderate AD dementia in the US and
- Frontotemporal Dementia
- Poster Presentation: Estimates of Frontotemporal Dementia by geographic regions (Gillis C; #P61) -
Wednesday, November 10 , throughFriday, November 12 .
- Poster Presentation: Estimates of Frontotemporal Dementia by geographic regions (Gillis C; #P61) -
Biogen will host webcasts of its oral presentations on EMBARK and plasma ptau181 on the investors section of Biogen’s website at investors.biogen.com concurrent with the presentation times indicated above. Following the webcasts, archived versions will be available on the website.
About ADUHELM® (aducanumab-avwa) injection 100 mg/mL solution
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).
Aducanumab-avwa is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.
ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a common side effect that does not usually cause any symptoms but can be serious. Although most people do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea. The patient’s healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. ADUHELM can also cause serious allergic reactions. The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain (ARIA); headache; and fall. Patients should call their healthcare provider for medical advice about side effects.
As of
Please click here for full Prescribing Information, including Medication Guide, for ADUHELM.
About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by
In 2020, Biogen launched a bold 20-year,
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Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of ADUHELM; the potential benefits, safety and efficacy of ADUHELM; the treatment of Alzheimer’s disease; results from the EMBARK study; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; clinical development programs, clinical trials and data readouts and presentations; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks associated with current and potential future healthcare reforms; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the
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