Nasdaq GlobeNewswire

Eisai and Biogen Present Detailed Results From Phase II Clinical Study of Elenbecestat in MCI and Mild to Moderate Alzheimer's Disease at Alzheimer's Association International Conference (AAIC) 2018

Del

TOKYO and CAMBRIDGE, Mass., July 25, 2018 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq:BIIB) (Headquarters: Cambridge, Massachusetts, United States, CEO: Michel Vounatsos, "Biogen") announced detailed results from a Phase II clinical study (Study 202) of the investigational oral BACE (beta amyloid cleaving enzyme) inhibitor elenbecestat (development code: E2609) at the Alzheimer's Association International Conference (AAIC) 2018 being held in Chicago, Illinois, United States, from July 22 to 26, 2018. This poster presentation was accepted as a Late Breaking Abstract for AAIC (Poster No.: P4-389).

Study 202 (ClinicalTrials.gov identifier NCT02322021) is a multicenter, randomized, double-blind, placebo-controlled parallel-group 18-month Phase II clinical study, conducted in the United States in patients with mild cognitive impairment (MCI) due to Alzheimer's disease, or mild to moderate dementia due to Alzheimer's disease (AD) with confirmed amyloid pathology by positron emission tomography (PET). Seventy patients were randomized to four treatment arms receiving elenbecestat (5, 15, or 50 mg) or placebo daily. During the study period, more than half the patients in the elenbecestat 5 mg and 15 mg arms were switched to the 50 mg arm. These patients received elenbecestat 50 mg for three months or longer. Analysis was carried out on the combination of patients in the initial 50 mg treatment arm plus the patients switched to the 50 mg arm, referred to collectively as the "50 mg total group arm" (38 patients). In addition to the primary safety objective, the study assessed amyloid pathology in the brain at 18 months as measured by amyloid PET as well as efficacy in terms of clinical symptoms, which were exploratory objectives in this study.

The primary objective of the study was to assess the safety and tolerability of elenbecestat after 18 months of treatment. The incidence of treatment-emergent adverse events was similar between elenbecestat and placebo, and no dose-dependent response was observed for adverse events. The six most common adverse events reported were upper respiratory tract infection, abnormal dreams and nightmares, contact dermatitis, headache, diarrhea, and falls. No adverse reactions suggestive of hepatic toxicity were observed in this study.

Regarding the accumulation of amyloid in the brain at 18 months as measured by PET via quantitative evaluation of Standard Uptake Value Ratio (SUVr) using the florbetaben PET tracer (n=28), a statistically significant reduction of brain amyloid load as compared to placebo was observed in the 50 mg total group arm with a reduction in SUVr of 0.104 (p=0.011). Although a small sample size, using the florbetapir PET tracer (n=7) demonstrated a statistically significant decrease in brain amyloid load compared to placebo for the 50 mg total group arm (reduction in SUVr of 0.227) at 18 months  (p=0.024).

Clinical efficacy was evaluated using the Clinical Dementia Rating Sum of Boxes (CDR-SB) rating scale. After 18 months of treatment, clinical assessment using CDR-SB demonstrated a mean treatment difference of -0.5 based off of an increase of 1.1 for the elenbecestat 50 mg total group arm (29 patients) versus an increase of 1.6 for the placebo group (12 patients). This represented a 31% slowing in rate of decline for the elenbecestat arm which is potentially considered to be clinically important.

Furthermore, based on information obtained from analyses of changes in CDR-SB and amyloid PET SUVr values from ADNI data, in a sub-population analysis of patients with baseline SUVr range between 1.4 and 1.9 who were identified in this study as being expected to have a higher rate of disease progression, there was 72% less decline in CDR-SB for patients in the 50 mg total group arm (n=10) versus placebo (n=5).  While the study was not powered to show statistical significance compared to placebo on clinical symptoms, the results suggest that elenbecestat could slow decline in cognitive function of patients with MCI due to Alzheimer's disease, or mild to moderate dementia due to Alzheimer's disease.

Elenbecestat, discovered by Eisai, has been jointly developed by Eisai and Biogen since March 2014. The two companies are currently conducting two global Phase III clinical studies (MISSION AD1/2) in early Alzheimer's disease.

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.

Biogen Safe Harbor

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements about results from the Phase II study of elenbecestat; the potential clinical effects of elenbecestat; the potential benefits, safety, and efficacy of elenbecestat; the clinical development program for elenbecestat; risks and uncertainties associated with drug development and commercialization; the treatment of Alzheimer's disease; Biogen's strategy and plans; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; and the potential of Biogen's commercial business and pipeline programs, including elenbecestat, BAN2401, and aducanumab. These forward-looking statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "except," "forecast," "intend," "may," "plan," "potential," "possible," "will," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation: the risk that clinical trials may not fully enroll or enrollment will take longer than expected; unexpected concerns may arise from additional data, analysis, or results obtained during clinical trials; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including elenbecestat, BAN2401, and/or aducanumab; the occurrence of adverse safety events; Biogen may encounter other unexpected hurdles; uncertainty of success in the development and potential commercialization of elenbecestat, BAN2401, and/or aducanumab, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect and enforce Biogen's data, intellectual property, and other proprietary rights and uncertainties relating to intellectual property claims and challenges; uncertainty as to whether the anticipated benefits and potential of Biogen's collaboration arrangement with Eisai can be achieved; product liability claims; and third party collaboration risks.. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this press release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Media Inquiries
Eisai Co., Ltd.
Public Relations Department
TEL: +81-(0)3-3817-5120

Eisai Inc.
Patricia_Councill@eisai.com
+1-201-746-2139

Biogen Inc.
Public Affairs 
TEL: +1-781-464-3260
public.affairs@biogen.com

 

<Notes to editors>

1. About Elenbecestat  (generic name, development code: E2609)

Elenbecestat is an oral BACE (beta amyloid cleaving enzyme) inhibitor discovered by Eisai currently being investigated in Phase III clinical studies for Alzheimer's disease. By inhibiting BACE, a key enzyme in the production of AB peptides, elenbecestat reduces AB 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 Alzheimer's disease 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 designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

2. About Study 202 (ClinicalTrials.gov identifier NCT02322021)

Study 202 is a placebo-controlled, double-blind, parallel-group, randomized, dose-finding study to evaluate the safety and tolerability of elenbecestat in 70 patients with mild cognitive impairment due to Alzheimer's disease (prodromal Alzheimer's disease) and mild to moderate dementia due to Alzheimer's disease. The study enrolled patients which met the core clinical research criteria of the U.S. National Institute on Aging - Alzheimer's Association for MCI due to AD or AD dementia, with an MMSE score of 16 or higher and confirmed accumulation of AB by PET screening. Patients were allocated to a total of four treatment arms, three for elenbecestat (5 mg/day: 17 patients, 15 mg/day: 19 patients, 50 mg/day: 17 patients) and one for placebo (17 patients). More than half the patients in the elenbecestat 5 mg and 15 mg treatment arms had their dose increased to 50 mg/day during the 18 month treatment period.  Mean duration of 50 mg total group arm on 50 mg/day was 11 months. The primary objectives are safety and tolerability after 18 months. Major exploratory endpoints are the change in accumulation of AB as measured by amyloid PET (35 patients) and the change in dementia assessment scales including CDR-SB and ADCOMS (41 patients), at 18 months compared to baseline.

3. Glossary of Terms

1) SUVr (Standard Uptake Value Ratio): SUVr calculates the ratio of strength of accumulation of PET tracer in a region of interest in the brain to an area of the brain (reference region) which shows low and stable accumulation of PET tracer. These SUVr values can be used to quantitatively compare and evaluate the accumulation of amyloid. 

2) CDR-SB (Clinical Dementia Rating scale Sum of Boxes):  The Clinical Dementia Rating (CDR) is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a patient's cognitive and functional performance in six areas: memory, orientation, judgment & problem solving, community affairs, home & hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and it is an appropriate item for evaluating the effectiveness of therapeutic drugs targeting early stage AD.

4. 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-amyloid beta (AB) protofibril antibody, while Biogen serves as the lead for co-development of aducanumab, Biogen's investigational anti-amyloid beta (AB) 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.

5. About Eisai Co., Ltd.

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 to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Leveraging the experience gained from the development and marketing of Aricept®, a treatment for Alzheimer's disease and dementia with Lewy bodies, Eisai has been working to establish a social environment that involves patients in each community in cooperation with various stakeholders including the government, healthcare professionals and care workers, and is estimated to have held over ten thousand dementia awareness events worldwide. As a pioneer in the field of dementia treatment, Eisai is striving to not only develop next generation treatments but also to develop diagnosis methods and provide solutions.

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

6. About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer's disease and dementia, neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.

Biogen routinely posts information that may be important to investors on its website at www.biogen.com. To learn more, please visit www.biogen.com and follow Biogen on social media - TwitterLinkedInFacebookYouTube.




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biogen Inc. via Globenewswire

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

WillScot Announces Closing of Warrant Exchange Offer11.12.2018 22:05Pressemelding

BALTIMORE, Dec. 11, 2018 (GLOBE NEWSWIRE) -- WillScot Corporation (“WillScot”) (NASDAQ: WSC), the specialty rental services market leader providing innovative modular space and portable storage solutions across North America, today announced the closing of its previously announced exchange offer (the “Exchange Offer”) relating to certain outstanding warrants issued in 2015 (the “Warrants”). Under the terms of the Exchange Offer, each Warrant holder had the opportunity to receive 0.18182 shares of WillScot Class A Common Stock, par value $0.0001 per share (“Common Stock”), for each Warrant tendered by the holder and exchanged pursuant to the Exchange Offer. As of the closing of the Exchange Offer on December 11, 2018, 45,131,827 outstanding Warrants were properly tendered and not withdrawn in the Exchange Offer. 45,031,827 of the Warrants tendered were public warrants, representing approximately 89% of the public warrants, and approximately 100,000 Warrants tendered were private warrant

DoubleVerify and InMobi Unite to Combat Mobile App Fraud11.12.2018 18:02Pressemelding

Partnership brings mobile app fraud prevention to advertisers globally NEW YORK, Dec. 11, 2018 (GLOBE NEWSWIRE) -- DoubleVerify ("DV"), the leading independent provider of marketing measurement software and analytics, today announced a partnership with InMobi, a global provider of enterprise platforms for marketers. As part of the partnership, DoubleVerify will provide always-on fraud filtering and measurement for mobile in-app advertising campaigns across the InMobi Exchange globally. The integration with InMobi covers pre-bid targeting for all InMobi Exchange impressions within the leading mobile in-app platform, as well as monitoring of post-bid fraud activity, such as spoofing – enabling InMobi to continuously refine the quality of its mobile ad inventory. “DV’s partnership with InMobi demonstrates our commitment to provide consistent, comprehensive quality coverage for global brand advertisers,” said Matt McLaughlin, COO at DoubleVerify. “With ad spend increasingly concentrated in

Claroty Announces Major Enhancements to Market-Leading Industrial Cybersecurity Platform11.12.2018 15:00Pressemelding

Groundbreaking multispectral data acquisition and network segmentation capabilities provide deeper OT network visibility and reduce risk for industrial enterprises and critical infrastructure providers NEW YORK, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Claroty, the leader in operational technology (OT) network protection, today announced several significant enhancements to its award-winning Continuous Threat Detection product and technology integrations with several leading industrial automation, network infrastructure and cybersecurity providers. Already the industry’s most complete industrial control systems (ICS) cybersecurity platform, this release incorporates new functionality to provide even more “extreme” visibility into ICS networks and help industrial enterprises decrease the risk of a cyberattack. The latest release of Claroty Continuous Threat Detection provides a large number of significant enhancements including: Virtual Zones and OT Network Segmentation – an innovative approach

INN Launches Battery Metals Channel11.12.2018 15:00Pressemelding

The new battery metals channel is designed to educate investors with original content and expert insight on the growing battery metals industry. VANCOUVER, British Columbia, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Investing News Network (INN) announces the launch of its battery metals channel. Responding to the growth and evolution of the battery metals market, this channel will host news, educational content and expert opinions on the lithium, cobalt, graphite, vanadium and manganese market segments. “INN has been a trusted source of information on the lithium, cobalt, graphite, vanadium and manganese markets for nearly a decade, and is excited to bring these sectors together under the battery metals umbrella,” said Nick Smith, CEO and publisher at INN. “Through connections with experts, our leading team of experienced writers creates original, insightful content on battery metals. INN educates investors in the industry by providing information they may never have access to on their own,” S

Galimedix Therapeutics Appoints Industry Veteran, Hermann Russ, M.D., Ph.D., Chief Scientific Officer11.12.2018 14:30Pressemelding

KENSINGTON, Md. and SHORASHIM, Israel, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Galimedix Therapeutics, which is developing new solutions for ophthalmic and neurodegenerative diseases, announced the appointment of Hermann Russ, M.D., Ph.D., as its chief scientific officer, effective December 1, 2018. Dr. Russ invented the use of the company’s lead molecule GAL-101/MRZ-99030 for the treatment of degenerative diseases of the retina, including glaucoma and dry macular degeneration. He is also co-inventor of the so-called “trigger effect” of GAL-101/MRZ-99030 and GAL-102/MRZ 14042, which is a unique reverse prion-like self-propagation mechanism of action important for the company’s eye drop and oral treatment regimens. “We are gratified that Dr. Russ is joining the Galimedix management team, as his knowledge in the field, as well as intimate experience with the compound, have already proven instrumental in the development of our company to date,” commented Andrew Pearlman, Ph.D., CEO of Galimedix

Farmako: Cannabis distributor to become gateway to Europe11.12.2018 10:00Pressemelding

Company is first to apply for a licence in the United Kingdom AAA-Team pushes to become gateway to Europe Company first to apply for distribution licences in UK Support of Canadian LP to obtain EU-GMP Focus on research and development FRANKFURT, Germany, Dec. 11, 2018 (GLOBE NEWSWIRE) -- The Frankfurt-based pharmaceutical company Farmako is a research-based pharmaceutical company that distributes medical cannabis. The company is active in all European markets that have created a legal basis for cannabinoid therapies. It is the first company for medical Cannabis pursue distribution licences in multiple European countries. Fort hat, it will rely on EU-GMP certified suppliers. The German market for medical cannabis is estimated at 19.1 million euros in 2018 and at 200 million Euros by 2019. For 2028, experts expect a market volume for medical cannabis of 7.8 billion euros in Germany, an increase by a factor of 400. The number of patients for cannabinoid therapies in Germany has grown from

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom