Jul, 06 2018 10:31 JST

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, Jul, 06 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. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.

Furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com


Contact:
NEC
Seiichiro Toda        
[email protected]
+81-3-3798-6511
Source: Eisai
Sectors: BioTech

Copyright ©2019 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Eisai Submits Application in Europe Seeking Approval for Fycompa as Treatment for Pediatric Patients With Epilepsy
February 13 2019 08:29 JST
 
Eisai and Purdue Pharma Present Efficacy and Safety Data from Second Pivotal Phase 3 Study
February 04 2019 11:57 JST
 
Eisai's Supplementary New Drug Application Submitted In Japan for Fycompa
January 30 2019 15:22 JST
 
Eisai Listed as a Global 100 Most Sustainable Corporation for the Fourth Time
January 22 2019 16:54 JST
 
Eisai's Notification Regarding Results of Voluntary Retirement Program
January 18 2019 13:33 JST
 
Eisai to Present Results of Post-Hoc Analyses of Lenvima (Lenvatinib) Phase III Reflect Study in Hepatocellular Carcinoma at 2019 Gastrointestinal Cancers Symposium
January 15 2019 13:31 JST
 
Eisai's New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States
January 15 2019 13:23 JST
 
Eisai's Etak Antimicrobial Spray Alpha Wins Nikkei Business Daily Awards for Superiority at the 2018 Nikkei Superior Products and Services Awards
January 04 2019 11:18 JST
 
Eisai's New Drug Application for Perampanel Designated for Priority Review by China National Medical Products Administration
January 04 2019 08:39 JST
 
Eisai: Bristol-Myers Squibb and H3 Biomedicine Announce Research Collaboration to Advance Novel Therapeutics Leveraging H3's RNA Splicing Platform
December 18 2018 10:38 JST
 
More Press release >>

Latest Press Release


More Latest Release >>