- For Print
- March 22, 2019
°®¶¹´«Ã½. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a total of seven presentations highlighting the latest data on its Alzheimer’s disease / dementia pipeline, including anti-amyloid beta (Aβ) protofibril antibody BAN2401 and oral beta amyloid cleaving enzyme (BACE) inhibitor elenbecestat will be given at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD) from March 26 to 31 in Lisbon, Portugal. BAN2401 and elenbecestat are being jointly developed by Eisai and Biogen Inc. (Headquarters: Cambridge, Massachusetts, United States, “Biogen”).
Five of the presentations will be given for BAN2401 and elenbecestat. The presentations include the study design for the Open Label Extension (OLE) portion of the BAN2401 Phase II clinical study in patients with mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease (collectively known as early Alzheimer’s disease) with confirmed amyloid pathology in the brain.
There will be a presentation of electrocardiogram (ECG) data to inform dose selection for E2027, a phosphodiesterase-9 (PDE9) inhibitor, discovered and developed solely by Eisai, in a Phase II study for dementia with Lewy bodies.
Eisai is aiming to realize prevention and cure of dementia through a holistic approach to dementia drug discovery research based on a foundation of over 30 years of experience of drug discovery activities in the area of Alzheimer’s disease / dementia. Eisai is striving to create innovative medicines as soon as possible in order to further contribute to addressing the unmet medical needs of, as well as increasing the benefits provided to, patients and their families.
Poster presentations:
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| Product, Poster No. | Poster title and scheduled presentation date (local time) |
|---|---|
|
BAN2401 Poster No.: 177 Abstract ID: ADPD9-2335 |
Population Pharmacokinetic (PK) and Exposure-Response (ER) Analyses for Efficacy and Safety of BAN2401 in Patients with Early Alzheimer’s Disease (AD) Poster Presentation | March 27 (Wed), 08:00-18:00 |
|
BAN2401 Poster No.: 178 Abstract ID: ADPD9-2329 |
Long-Term Safety and Tolerability of BAN2401 in Early Alzheimer’s Disease (EAD): An Open Label Extension (OLE) Study Design for BAN2401-G000-201 Poster Presentation | March 27 (Wed), 08:00-18:00 |
|
Elenbecestat Poster No.: 234 Abstract ID: ADPD-2340 |
Performance on the International Shopping List Test and Subsequent Amyloid PET Positivity Rates in the Elenbecestat MissionAD Phase 3 Program Poster Presentation | March 27 (Wed), 08:00-18:00 |
|
Elenbecestat Poster No.: 238 Abstract ID: ADPD-2318 |
Predicting Abnormal Memory From Assessment of Cognition Using the CBB in the Elebecestat MissionAD Global Phase 3 Program Poster Presentation | March 27 (Wed), 08:00-18:00 |
|
Elenbecestat Poster No.: 425 Abstract ID: ADPD-2237 |
Evaluation of Tau Deposition in Amyloid Positive MCI or Mild-AD Dementia Subjects from the Elenbecestat MissionAD Program Using [18F]PI-2620 PET Poster Presentation | March 27 (Wed) , 08:00-18:00 |
|
E2027 Poster No.: 670 Abstract ID: ADPD9-1615 |
Concentration Response Modeling of ECG Data for E2027 to Inform Dose Selection for Phase 2 Dementia in Lewy Body Study Poster Presentation | March 27 (Wed), 08:00-18:00 |
|
General AD Poster No.: 333 Abstract ID: ADPD-0345 |
Tau Proteoforms in Alzheimer’s Disease and Progressive Supranuclear Palsy Brains Poster Presentation | March 29 (Fri), 08:00-18:00 |
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°®¶¹´«Ã½.
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[Notes to editors]
- 1. °®¶¹´«Ã½ BAN2401
BAN2401 is a humanized monoclonal antibody for Alzheimer’s disease that is the result of a strategic research alliance between Eisai and BioArctic. BAN2401 selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates that are thought to contribute to the neurodegenerative process in Alzheimer’s disease. As such, BAN2401 may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of Alzheimer’s disease pursuant to an agreement concluded with BioArctic in December 2007. In March 2014 Eisai and Biogen entered into a joint development and commercialization agreement for BAN2401 and the parties amended that agreement in October 2017.
Currently, the open label extension phase of a Phase II clinical study (Study 201) targeting patients who were enrolled in the study is ongoing.
- 2. °®¶¹´«Ã½ elenbecestat (generic name, development code: E2609)
Elenbecestat is an oral BACE (beta amyloid cleaving enzyme) inhibitor currently being investigated in Phase III clinical studies for Alzheimer’s disease (AD) discovered by Eisai. By inhibiting BACE, a key enzyme in the production of Aβ peptides, elenbecestat reduces Aβ production, which is thought to lead to a reduction in amyloid plaque formations caused by the aggregation of toxic oligomers and protofibrils in the brain. Currently, two global Phase III clinical studies (MISSION AD1/2) of elenbecestat in early AD including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early stages of mild AD are underway. In addition, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of elenbecestat, a process allowing priority reviews by the FDA for drugs deemed as having potential to treat serious conditions and tackle key unmet medical needs.
- 3. °®¶¹´«Ã½ E2027
Discovered by Eisai, E2027 is a selective phosphodiesterase (PDE) 9 inhibitor. Inhibiting PDE9 reduces the degradation of cyclic GMP (cGMP) which is critical to signal transmission among cells, and helps maintain the concentration of cGMP in the brain. Eisai is currently developing E2027 as a new treatment for dementia with Lewy bodies.