Benzinga | Nov 3, 2021 09:16AM EDT

Biogen Highlights Late-Breaking Presentations, Added New Presentations For Clinical Trials On Alzheimer's Disease Meeting Nov. 9-12

* Late breaker will show ADUHELM(tm) 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.

CAMBRIDGE, Mass., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) announced the company will present a variety of new data from its Alzheimer's disease product portfolio and clinical development pipeline at the upcoming annual Clinical Trials on Alzheimer's Disease conference (CTAD), held November 9-12 virtually and in Boston, Massachusetts. Biogen's contributions to the conference are driven in part by analyses from the largest clinical trial dataset in early Alzheimer's disease research. This includes over 3,000 patients in Phase 3 trials and approximately 1,700 patients in the ADUHELM (aducanumab-avwa) redosing trial, EMBARK.

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 Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. "The clinical insights we can derive from our data at CTAD are meaningful. These can help inform clinician, patient and caregiver choice and future treatment decisions, as well as advance the field's understanding of this devastating disease."

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 Thursday, November 11, at 5:10 p.m. EST.

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 Tuesday, November 9, at 8:00 a.m. EST.

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

* 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

* 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 on Tuesday, November 9, 8:00 a.m. EST

* 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, through Friday, 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, through Friday, 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, through Friday, 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, through Friday, November 12. Poster Presentation: Global prevalence of Alzheimer's disease across disease stages (Gustavsson A; #RP36) - Wednesday, November 10, through Friday, November 12.

* Frontotemporal Dementia Poster Presentation: Estimates of Frontotemporal Dementia by geographic regions (Gillis C; #P61) - Wednesday, November 10, through Friday, November 12.

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.