New Data on Alzheimer Disease Research from Biogen Planned for Release at CTAD 2023 Meeting

New data on therapeutics in development for the treatment of Alzheimer disease will be presented by biotechnology company Biogen during several sessions at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) meeting taking place October 24-27 in Boston, Mass.

Updates are planned on 2 phases of the phase 1b study that is evaluating exploratory clinical outcomes related to reduction of tau in early Alzheimer disease. Findings from multiple ascending dose and long-term extension phases will be discussed.

Preliminary data on a subcutaneous formulation of lecanemab, (Leqembi®) will be highlighted in a Wednesday evening late-breaking symposium, along with early assessments from a second study that is evaluating the potential role of tau as a predictive biomarker.

“We believe these new data represent an important step in our effort to both optimize patient outcomes with current treatments while simultaneously advancing the next wave of breakthroughs in Alzheimer’s disease,” said Priya Singhal, MD, MPH, Biogen head of development in a company statement. “We’ve reached a potential tipping point in this complex field and remain determined to continue moving forward with the community to help the millions of people impacted by Alzheimer’s disease.”

The key onsite presentations:

Wednesday, October 25, 2023

8:30 am Late-breaking oral presentation: Pooled ENGAGE/EMERGE integrated placebo-controlled period and long-term extension (LTE) topline results: slower clinical progression at week 134 in aducanumab-treated patients that became amyloid PET negative at week 78

10:50 am Late-breaking oral presentation: Exploratory clinical outcomes from BIIB080 (MAPT ASO) Phase 1b multiple ascending dose and long-term extension study in mild Alzheimer’s disease.

5:25 pm Late-breaking symposium 4: Lecanemab for early Alzheimer’s disease: long-term outcomes, predictive biomarkers, and novel subcutaneous administration

The presentation will include:

• The latest data from the CLARITY AD optional tau PET longitudinal sub-study.
• A post-hoc analysis of the low and intermediate + high-tau subgroups, including the low-tau subgroup specifically studied in the Phase 3 core study, and data from the open-label extension study.
• An update on the investigational subcutaneous formulation with the effect on amyloid as measured by amyloid PET and interim safety.

Thursday, October 26, 2023

4:35 pm Oral presentation: Precision medicine analysis of heterogeneity in individual-level treatment response to beta-amyloid removal in early Alzheimer’s disease:

Friday, October 27, 2023

2:00 pm Late-breaking oral presentation: Aducanumab phase 3b EMBARK study interim analysis: topline safety results

Source: Biogen to present new data at the Clinical Trials on Alzheimer's Disease (CTAD) 2023 meeting. News release. Biogen. October 19, 2023. Accessed October 20, 2023. https://investors.biogen.com/news-releases/news-release-details/biogen-present-new-data-clinical-trials-alzheimers-disease-ctad