Biogen (NASDAQ:BIIB) Highlights New Lecanemab Findings at CTAD

Biogen Inc. (Nasdaq: BIIB) will present scientific data at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference, December 1-4 in San Diego.

Presentations will include data on LEQEMBI® (lecanemab-irmb), including findings on subcutaneous administration for initiation dosing, the benefits of continued therapy, estimated time savings over 10 years of treatment, and real-world experience from a post-marketing observational study in Japan and the ALZ-NET registry. The company will also share new insights into BIIB080, an investigational antisense oligonucleotide (ASO) therapy, from a healthy-volunteer biodistribution study, as well as research that helps inform understanding of disease progression.

Priya Singhal, M.D., M.P.H., Head of Development at Biogen, said the company looks forward to sharing data that explore LEQEMBI’s potential for initiation dosing and how it may expand treatment options for patients and care partners across both phases of the treatment journey. Singhal added that the breadth of data at CTAD underscores the growing evidence supporting the long-term benefits of continued treatment with LEQEMBI and reflects Biogen’s ongoing commitment to advancing scientific understanding of Alzheimer’s disease.

Key scientific sessions and presentations include a late-breaking symposium, “Lecanemab Subcutaneous Formulation for Treatment Initiation in Early Alzheimer’s Disease: Optimizing Patient Care with a Potential New Option,” on Wednesday, December 3 from 3:10-3:50 p.m. PT.

Oral presentations include:

  • “The Effects of Lecanemab Treatment on Soluble CSF Aβ Protofibrils in Clarity AD,” on Tuesday, December 2 from 1:40-1:55 p.m. PT
  • “Benefit Continues to Accumulate When Treatment is Continued Beyond Plaque Clearance Estimating Accumulated or Maintained Treatment Benefit in the CLARITY AD and TRAILBLAZER-ALZ2 Trials,” on Tuesday, December 2 from 5:05-5:20 p.m. PT
  • “Estimating the 10-Year Time-Savings Benefits of Lecanemab Treatment,” on Wednesday, December 3 from 2:40-2:55 p.m. PT
  • “Interim Analysis of Post-Marketing Observational Study of Lecanemab in Japan,” on Thursday, December 4 from 11:40-11:55 a.m. PT

Poster presentations include:

  • “Baseline Characteristics and Preliminary Safety from a Multicenter, Safety Surveillance Study of Lecanemab Treatment for Alzheimer’s Disease in Real-World Clinical Practice” on Tuesday, December 2 from 7:15 a.m.-5:30 p.m. PT
  • “Real-World Clinical Safety and Patient-Reported Outcomes of Treatment with Lecanemab in a New England Alzheimer’s Disease Center” on Tuesday, December 2 from 7:15 a.m.-5:30 p.m. PT
  • “Stability and Improvement in Early Alzheimer’s Disease with Lecanemab: Sub-analysis from a United States Multicenter, Retrospective, Real-World Study” on Tuesday, December 2 from 7:15 a.m.-5:30 p.m. PT
  • “Biodistribution of Radiolabeled MAPT Antisense Oligonucleotide BIIB080 Following Intrathecal Administration in Healthy Adults,” on Wednesday, December 3 from 7:15 a.m.-5:30 p.m. PT
  • “Baseline Study-Partner Reported but not Participant Self-Reported ECog-12 score is Associated with Subsequent Cognitive Progression on CDR-SB over 78 Weeks of Follow-up,” on Thursday, December 4 from 7:15 a.m. -5:00 p.m. PT

LEQEMBI (lecanemab-irmb) is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). The U.S. Food and Drug Administration (FDA) granted LEQEMBI traditional approval on July 6, 2023, for the treatment of Alzheimer’s disease (AD) in the U.S. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease.

Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

BIIB080 is an investigational antisense oligonucleotide (ASO) therapy designed to target microtubule-associated protein tau (MAPT) mRNA to reduce the production of tau protein. Abnormal accumulation of tau in the brain is a hallmark of Alzheimer’s disease and is associated with neurodegeneration and cognitive decline. BIIB080 is currently being evaluated in a Phase 2 clinical study (NCT05399888) in individuals with early Alzheimer’s disease.

Biogen, founded in 1978, pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and communities. The company applies deep understanding of human biology and leverages different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Biogen’s approach is to take bold risks, balanced with return on investment to deliver long-term growth.

Madeleine Shin, Biogen Media Contact, + 1 781 464 3260, public.affairs@biogen.com

Tim Power, Biogen Investor Contact, +1 781 464 2442, IR@biogen.com

Source: Biogen

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