Top Page | English | 简体中文 | 繁體中文 | 한국어 | 日本語
Friday, 6 July 2018, 09:31 HKT/SGT
Share:
    

Source: Eisai
Eisai and Biogen Announce Positive Topline Results of the Final Analysis for BAN2401 At 18 Months
- The final analysis at 18 months of the 856 patient Phase II clinical study in early Alzheimer's disease demonstrated statistically significant slowing in clinical decline and reduction of amyloid beta accumulated in the brain
- First late-stage study data successfully demonstrating potential disease-modifying effects on both clinical function and amyloid beta accumulation in the brain
- New data provide compelling evidence to further support amyloid hypothesis as a therapeutic target for Alzheimer's disease

TOKYO, July 6, 2018 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. (NASDAQ: BIIB) announced positive topline results from the Phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer's disease. The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer's Disease Composite Score (ADCOMS) and on reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography).

Study 201 (ClinicalTrials.gov identifier NCT01767311) is a placebo-controlled, double-blind, parallel-group, randomized study in 856 patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's dementia (collectively known as early Alzheimer's disease) with confirmed amyloid pathology in the brain. Efficacy was evaluated at 18 months by predefined conventional statistics on ADCOMS, which combines items from the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog), the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale and the Mini-Mental State Examination (MMSE) to enable sensitive detection of changes in early AD symptoms. Patients were randomized to five dose regimens, 2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10 mg/kg monthly and 10 mg/kg biweekly, or placebo.

Topline results of the final analysis of the study demonstrated a statistically significant slowing of disease progression on the key clinical endpoint (ADCOMS) after 18 months of treatment in patients receiving the highest treatment dose (10 mg/kg biweekly) as compared to placebo. Results of amyloid PET analyses at 18 months, including reduction in amyloid PET standardized uptake value ratio (SUVR) and amyloid PET image visual read of subjects converting from positive to negative for amyloid in the brain, were also statistically significant at this dose. Dose-dependent changes from baseline were observed across the PET results and the clinical endpoints. Further, the highest treatment dose of BAN2401 began to show statistically significant clinical benefit as measured by ADCOMS as early as 6 months including at 12 months.

BAN2401 demonstrated an acceptable tolerability profile through 18 months of study drug administration. The most common treatment emergent adverse events were infusion-related reactions and Amyloid Related Imaging Abnormalities (ARIA). Infusion related reactions were mostly mild to moderate in severity. Incidence of ARIA-E (edema) was not more than 10% in any of the treatment arms, and less than 15% in patients with APOE4 at the highest dose per the study protocol safety and reporting procedures.

Detailed results of the study will be presented at future academic conferences.

"The 18-month results of the BAN2401 trial are impressive and provide important support for the amyloid hypothesis," said Jeff Cummings, M.D., founding director, Cleveland Clinic Lou Ruvo Center for Brain Health. "I look forward to seeing the full data set shared with the broader Alzheimer's community as we advance against this devastating disease."

"This is the first late-stage anti-amyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "We will discuss these very encouraging results with regulatory authorities to determine the best path forward. We continue to work towards the goal of delivering BAN2401 to patients and healthcare professionals as early as possible."

"The prospect of being able to offer meaningful disease-modifying therapies to individuals suffering from this terrible disease is both exciting and humbling," said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. "These BAN2401 18-month data offer important insights in the investigation of potential treatment options for patients with Alzheimer's disease and underscores that neurodegenerative diseases may not be as intractable as they once seemed."

As reported in December 2017, the study did not achieve its primary outcome measure which was designed to enable a potentially more rapid entry into Phase III development based on Bayesian analysis at 12 months of treatment. Upon the final analysis at 18 months using predefined conventional statistical method, the study did demonstrate a statistically significant slowing of disease progression on the key clinical endpoint (ADCOMS) after 12 months of treatment in patients receiving the highest treatment dose (10 mg/kg biweekly) as compared to placebo.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.


About Eisai

Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.

Contact:
NEC
Seiichiro Toda        
s-toda@cj.jp.nec.com
+81-3-3798-6511


July 6, 2018 09:31 HKT/SGT
Source: Eisai

Eisai (TSE: 4523)

Topic: Press release summary
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2018 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.



Eisai
July 11, 2018 15:32 HKT/SGT
Eisai: Oral Antifungal Agent Nailin Capsules 100mg to be Launched in Japan
July 10, 2018 10:14 HKT/SGT
Eisai: Oral Presentation on Phase II Clinical Study Results of BAN2401 to be Presented at Alzheimer's Association International Conference (AAIC) 2018
July 9, 2018 14:07 HKT/SGT
Eisai: Results from Two Phase 3 Clinical Trials of Chronic Constipation Treatment "GOOFICE 5mg Tablet" Published in The Lancet Gastroenterology & Hepatology
July 4, 2018 17:18 HKT/SGT
Eisai Listed for 17th Consecutive Year in FTSE4GOOD Index Series
July 2, 2018 15:36 HKT/SGT
Eisai to Give Oral Presentation on Results of Phase III Head-to-Head Clinical Study of Lemborexant in Insomnia Disorder
June 22, 2018 10:58 HKT/SGT
Eisai Selected for Membership in MSCI Japan Empowering Women Index (WIN)
June 21, 2018 09:51 HKT/SGT
AbbVie and Eisai Announce the Launch of HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL
June 14, 2018 09:11 HKT/SGT
Eisai: Industry-Academia-Government Joint Development Agreement Concerning Nucleic Acid Drug Discovery Research
June 13, 2018 11:53 HKT/SGT
Eisai to Establish New Research Facility "Eisai Center for Genetics Guided Dementia Discovery" in Cambridge, Massachusetts, USA
June 11, 2018 11:44 HKT/SGT
AbbVie and Eisai Announce the Launch of HUMIRA Pen, an Auto-Injector Formulation for Fully Human Anti-TNF-alpha Monoclonal Antibody HUMIRA
More news >>
 News Alerts
Copyright © 2018 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Privacy Policy | Terms of Use | RSS
US: +1 800 291 0906 | Beijing: +86 10 8405 3688 | Hong Kong: +852 2217 2912 | Singapore: +65 6304 8926 | Tokyo: +81 3 6721 7212

Connect With us: