NEW HOPE ON ALZHEIMER ?!
Thirteen presentations to be given including late breaking Phase 2 study results of BAN2401 and elenbecestat
WOODCLIFF LAKE, N.J., July 18, 2018 — Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announces today that 13 posters and presentations from its robust Alzheimer’s disease pipeline, including the Phase 2 clinical study (Study 201) of the anti-amyloid beta (Aβ) protofibril antibody BAN2401, as well as a Phase 2 clinical study (Study 202) of the oral BACE (beta amyloid cleaving enzyme) inhibitor elenbecestat (E2609), will be highlighted at the Alzheimer’s Association International Conference (AAIC) 2018, in Chicago from July 22-26, 2018.
Three of the compounds being presented are jointly developed by Eisai and Biogen Inc.: BAN2401, elenbecestat, and the anti-Aβ antibody aducanumab.
As previously announced, the BAN2401 oral presentation will focus on the results of Study 201 (ClinicalTrials.gov identifier: NCT01767311) in early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia). Eisai and Biogen announced that Study 201 achieved statistical significance at 18 months based on key predefined endpoints evaluating the efficacy on slowing progression in the Alzheimer’s Disease Composite Score (ADCOMS) and the reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography). This study marks the first time that late-stage study data has successfully demonstrated potential disease-modifying effects on both clinical function and amyloid beta accumulation in the brain. The most common treatment emergent adverse events reported were infusion-related reactions and Amyloid Related Imaging Abnormalities (ARIA).
The BAN2401 Study 201 data presentation will be webcast live. To access the live webcast, please visit the Investors section of Eisai’s website on July 25th at 3:30pm CDT at https://www.eisai.com/ir/index.html.
A poster presentation highlighting elenbecestat will be made as a late-breaking abstract on the Phase 2 results of Study 202 (ClinicalTrials.gov identifier NCT02322021) in patients with mild cognitive impairment and mild-to-moderate dementia due to Alzheimer’s disease. On June 5, 2018, Eisai and Biogen announced positive elenbecestat topline results of Study 202 at 18 months which demonstrated acceptable safety and tolerability (primary endpoint), as well as a statistically significant effect on brain amyloid levels in the brain as measured by amyloid PET (exploratory endpoint). A numerical slowing of cognitive decline in functional clinical scales of a potential clinically important difference was also observed. The most common adverse events reported were upper respiratory tract infection, contact dermatitis, headache, abnormal dreams and nightmares, diarrhea, and falls. Elenbecestat is currently being investigated in two ongoing Phase 3 clinical studies, MISSIONAD1 (ClinicalTrials.gov identifier: NCT02956486) and MISSIONAD2 (ClinicalTrials.gov identifier: NCT03036280), in patients with early Alzheimer’s disease.
An oral and poster presentation will be given featuring aducanumab on the long-term administration of the compound based on a Phase 1B clinical study being conducted by Biogen. Currently, Eisai and Biogen are advancing two Phase 3 clinical studies, ENGAGE (ClinicalTrials.gov identifier: NCT02477800) and EMERGE (ClinicalTrials.gov identifier: NCT02484547), on aducanumab.
Eisai will also discuss its novel phosphodiesterase-9 inhibitor, E2027, which will include an oral presentation on the results of a Phase 1 study (ClinicalTrials.gov identifier: NCT03467152) as well as poster presentations on clinical and non-clinical studies. Discovered and developed by Eisai, E2027 is currently being investigated in a Phase 2 clinical study as a potential treatment for dementia with Lewy bodies.
Eisai and Purdue will also present baseline data from a first-in-kind Phase 2 study, Study 202 (ClinicalTrials.gov identifier: NCT03001557), of lemborexant – an investigational sleep-wake regulation agent – in patients with mild-to-moderate Alzheimer’s disease dementia who suffer from Irregular Sleep-Wake Rhythm Disorder (ISWRD).
“For more than 30 years, Eisai has vigorously pursued better ways to treat and slow down the progression of Alzheimer’s disease,” said Ivan Cheung, Chairman & CEO, Eisai Inc. “Now, with a robust pipeline that is gaining momentum, Eisai continues to make strides toward breaking new ground in Alzheimer’s disease and help usher in a new era of treatment against this dreaded disease.”
Major presentations at AAIC 2018:
| Product/Presentation number | Abstract title and scheduled presentation date and time (Central Daylight Time) |
| Late Breaking Presentations | |
| BAN2401 Abstract ID: 27531 Session No.: DT-01-07 (Late Breaking Oral Presentation) |
Treatment of Early AD Subjects with BAN2401, an Anti-Aβ Protofibril Monoclonal Antibody, Significantly Clears Amyloid Plaque and Reduces Clinical Decline July 25 (Wed), 3:30-4:00 PM |
| Elenbecestat Abstract ID: 27524 Poster No.: P4-389 (Late Breaking Poster Presentation) |
Elenbecestat, E2609, a BACE Inhibitor: Results from a Phase-2 Study in Subjects with Mild Cognitive Impairment and Mild-to-Moderate Dementia Due to Alzheimer’s Disease July 25 (Wed), 1:00-2:00 PM |
| Oral Presentations | |
| Aducanumab Abstract ID: 22962 Session No.: O1-09 |
24-Month Analysis of Change from Baseline in Clinical Dementia Rating Scale Cognitive and Functional Domains in PRIME: A Randomized Phase 1B Study of the Anti-Amyloid Beta Monoclonal Antibody Aducanumab July 22 (Sun), 3:15-3:30 PM |
| E2027 Abstract ID: 24975 Session No.: O1-12-06 |
Phase 1 Multiple Ascending Dose (MAD) Study of Phosphodiesterase-9 Inhibitor E2027: Confirmation of Target Engagement and Selection of Phase 2 Dose in Dementia with Lewy Bodies July 22 (Sun), 5:30-5:45 PM |
| Poster Presentations | |
| Elenbecestat Abstract ID: 24768 Poster No.: P1-040 |
Elenbecestat, a Novel BACE Inhibitor, Demonstrates Similar Pharmacokinetics and Tolerability in Japanese Subjects with Multiple Dosings July 22 (Sun), 9:30-10:30 AM |
| Aducanumab Abstract ID: 22959 Poster No.: P1-041 |
24-Month Analysis of APOE ε4 Carriers in PRIME: A Randomized Phase 1B Study of the Anti-Amyloid Beta Monoclonal Antibody Aducanumab July 22 (Sun), 9:30-10:30 AM |
| E2027 Abstract ID: 24835 Poster No.: P1-055 |
E2027, a Novel Phosphodiesterase-9 (PDE9) Inhibitor in Development for Treatment of Dementia with Lewy Bodies (DLB), Showed No Clinically Significant Drug Interaction with Diltiazem July 22 (Sun), 9:30-10:30 AM |
| Aducanumab Abstract ID: 22897 Poster No.: P1-339 |
Cognitive and Other Neuropsychological Assessments Documented in Electronic Health Records Prior to or at Alzheimer’s Disease Diagnosis July 22 (Sun), 12:00-1:00 PM |
| General Alzheimer’s disease Abstract ID: 25196 Poster No.: P1-361 |
Assessing Function in Early AD: Analysis of Alzheimer’s Disease Neuroimaging Initiative (ADNI) 3 Data for the Financial Capacity Instrument Short Form (FCI-SF) July 22 (Sun), 12:00-1:00 PM |
| E2027 Abstract ID: 24657 Poster No.: P3-062 |
Effect of Repeated Administration of E2027, a Novel Phosphodiesterase-9 Inhibitor, on Cyclic GMP Levels in Rat Cerebrospinal Fluid July 24 (Tue), 9:30-10:30 AM |
| Lemborexant Abstract ID: 21595 Poster No.: P3-015 |
Circadian Rhythm Characteristics Measured with Actigraphy in Patients with Irregular Sleep-Wake Rhythm Disorder and Alzheimer’s Disease Dementia July 24 (Tue), 9:30-10:30 AM |
| General Alzheimer’s disease Abstract ID: 23164 Poster No.: P4-075 |
Lumipulse® G Total Tau to β-Amyloid 1-42 Ratio Cut-Point Determination for Amyloid Eligibility Screening July 25 (Wed), 9:30-10:30 AM |
| General Alzheimer’s disease Abstract ID: 27140 Poster No.: P4-291 |
Baseline Florbetapir Amyloid PET Standard Uptake Value Ratio SUVR Can Predict Clinical Progression in Prodromal AD July 25 (Wed), 1:00-2:00 PM |
This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.
- Please note AAIC embargo policy: All materials submitted to AAIC are embargoed for publication and broadcast until the officially scheduled date and time of presentation.
- 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.
- About the Joint Development Agreement between Eisai and Biogen for Alzheimer’s Disease: Eisai and Biogen are widely collaborating on the joint development and commercialization of Alzheimer’s disease treatments. Eisai serves as the lead in the co-development of elenbecestat, a BACE inhibitor, and BAN2401, an anti-Aβ protofibril antibody, while Biogen serves as the lead for co-development of aducanumab, Biogen’s investigational anti-Aβ antibody for patients with Alzheimer’s disease, and the companies plan to pursue marketing authorizations for the three compounds worldwide. If approved, the companies will also co-promote the products in major markets, such as the United States, the European Union and Japan.
- Discovered by Eisai, lemborexant is being jointly developed by Eisai and Purdue Pharma.
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.
Contacts:
Eisai Inc.
Patricia Councill
201-746-2139
[email protected]
SOURCE Eisai Inc.
