Eisai and Biogen Announce Positive Topline Results of the Final Analysis for BAN2401 at 18 Months
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 and CAMBRIDGE, Mass., July 05, 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 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.
Biogen Safe Harbor Statement
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 about results from the Phase 2 study of BAN2401, the potential clinical effects of BAN2401, risks and uncertainties associated with drug development and commercialization, the potential benefits, safety and efficacy of BAN2401, and therapies for other neurological diseases, the timing and status of current and future regulatory filings, the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai and the potential of Biogen's commercial business and pipeline programs, including BAN2401, elenbecestat and aducanumab. These forward-looking statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "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 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, unexpected concerns that 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 BAN2401, elenbecestat and/or aducanumab; the occurrence of adverse safety events; risks of unexpected costs or delays; the risks of other unexpected hurdles; uncertainty of success in the development and potential commercialization of BAN2401, elenbecestat 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 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.
| Eisai Co., Ltd.
Public Relations Department
Public Relations Department
| Biogen Inc.
<Notes to editors>
1. About 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 Abeta 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.
2. About ADCOMS
Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR-SB (Clinical Dementia Rating Sum of Boxes) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. This Study 201 utilizes ADCOMS as its key endpoint for assessing clinical symptoms.
3. About Amyloid PET Imaging
Amyloid PET (Positron Emission Tomography) imaging is a diagnostic method that enables the visualization of amyloid plaque present in the brain as well as the quantitative evaluation of amyloid plaque distribution and accumulation in the brain via administration of a minute amount of PET tracer, which specifically binds to amyloid plaque and marks it with positron. Amyloid PET imaging enables the assessment of pathology change and assistance of diagnosis of patients with Alzheimer's-disease including MCI, and estimates the clinical effect of disease modifiers based on the amyloid hypothesis.
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 (Abeta) protofibril antibody, while Biogen serves as the lead for co-development of aducanumab, Biogen's investigational anti-amyloid beta (Abeta) 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.
As to BAN2401 and elenbecestat, both companies will equally split overall costs, including research and development expenses. Eisai will book all sales for elenbecestat and BAN2401 following marketing approval and launch, and profits will be equally shared between the companies.
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 Weissman, 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 - Twitter, LinkedIn, Facebook, Youtube.
7. About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease. The company also develops a potential treatment for Complete Spinal Cord Injury. BioArctic focuses on innovative treatments in areas with high unmet medical needs. The company was founded in 2003 based on innovative research from Uppsala University, Sweden. Collaborations with universities are of great importance to the company together with our strategically important global partners in the Alzheimer (Eisai) and Parkinson (AbbVie) projects. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market- and out-licensing potential. BioArctic's B-share is listed on Nasdaq Stockholm Mid Cap (STO:BIOA B). www.bioarctic.com.
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
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
Real World Cloud Orchestration Facilitates Easy Migration to All-IP18.4.2019 22:05:00 CEST | Pressemelding
For All-IP service providers in Malta and the Netherlands, Patton Cloud edge orchestration has lowered costs with fast, simple activation and management of enterprise IP-Telephony services SmartNode VoIP… More than Just Talk! BERN, Switzerland, April 18, 2019 (GLOBE NEWSWIRE) -- Patton—a U.S. network-equipment manufacturer and multi-national provider of enabling solutions for virtualized network function virtualization (NFV) SD-WAN, All-IP, and unified communications (UC) services—has saved the day for Dutch and Maltese national IP-communications providers with its Patton Cloud network edge orchestration service. VIDEO: Cloud Powered Services Netherlands ISDN Services are going away in the Netherlands. Yet scores of business subscribers can't simply jump into an All-IP network overnight. Investments in ISDN-based systems, fused with established business-processes, preclude such reckless dismantling of on-premise legacy systems. Business customers need flexibility to manage migration to
Acreage Holdings Announces Signing of Arrangement Agreement18.4.2019 17:02:00 CEST | Pressemelding
FRANKFURT, Germany, April 18, 2019 (GLOBE NEWSWIRE) -- Acreage Holdings, Inc. (“Acreage”) (CSE:ACRG.U) (OTC:ACRGF) (FSE:0VZ) and Canopy Growth Corporation (“Canopy Growth”) (TSX:WEED) (NYSE:CGC) (together, the “Companies”) entered into a definitive arrangement agreement (the "Agreement") that grants Canopy Growth the right to acquire 100 percent of the shares of Acreage (the “Right”), with a requirement to do so at such time as cannabis production and sale becomes federally legal in the United States of America (the "Transaction"), subject to obtaining the requisite prior approval of the shareholders of each of Acreage and Canopy Growth, respectively (the “Shareholder Approval”), as well as the approval of the Supreme Court of British Columbia, Canada (the “Court Approval”). Following the Shareholder Approval and the Court Approval, under the terms of the Agreement, and upon exercise of the Right, the total consideration payable pursuant to the Transaction is valued at approximatel
WillScot to Participate at the Credit Suisse Extreme Services Conference18.4.2019 16:19:00 CEST | Pressemelding
BALTIMORE, April 18, 2019 (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 that Brad Soultz, President and Chief Executive Officer, and Tim Boswell, Chief Financial Officer, will host a day of one-on-one and group meetings with investors at the Credit Suisse Extreme Services Conference to be held at Credit Suisse’s New York City office, on Tuesday, May 7, 2019. About WillScot Corporation Headquartered in Baltimore, Maryland, WillScot is the public holding company for the Williams Scotsman family of companies. WillScot trades on the Nasdaq stock exchange under the ticker symbol "WSC," and is the specialty rental services market leader providing innovative modular space and portable storage solutions across North America. WillScot is the modular space supplier of choice for the construction, education, health care, governm
TrueCommerce Datalliance Releases First Platform Update of 201918.4.2019 16:00:00 CEST | Pressemelding
Supply chain software company expands self-service options, more control for customers’ data CINCINNATI, April 18, 2019 (GLOBE NEWSWIRE) -- TrueCommerce, a global provider of trading partner connectivity, integration and unified commerce solutions, has announced today that TrueCommerce Datalliance, its division focusing on vendor managed inventory (VMI) and collaborative replenishment (CR) software, has released its first of three software updates for 2019. In addition to general reliability and stability fixes, the update provides customers with more control over updating specific fields and who has access to that information, as well as adding store-driven demand. Doug Bethea, Vice President of Consumer Goods Solutions said, “Every update is multifaceted. We implement necessary security changes and adjust code to optimize performance for our customers. We also bring our own ideas as value-adds. Additionally, we are always working with customers to implement advanced features as it is
Constellation Brands Enters Into Agreement with Canopy Growth Corporation to Modify Warrants and Other Rights18.4.2019 15:33:00 CEST | Pressemelding
VICTOR, N.Y., April 18, 2019 (GLOBE NEWSWIRE) -- Constellation Brands, Inc. (NYSE: STZ and STZ.B), a leading beverage alcohol company, today announced that it plans to enter into an agreement with Canopy Growth Corporation (“Canopy”) (TSX: WEED, NYSE: CGC), a leading diversified cannabis company, to modify certain warrants and other rights. These changes are the result of Canopy’s intentions to acquire Acreage Holdings, Inc. (“Acreage”) upon U.S. Federal cannabis legalization. Earlier today, Canopy announced (see Canopy press release “Canopy Growth Announces Option to Acquire Leading U.S. Multi-state Cannabis Operator, Acreage Holdings”) it has entered into an agreement with Acreage, a U.S. multi-state cannabis operator, where Canopy plans to acquire the shares of Acreage upon U.S. Federal cannabis legalization (the “Triggering Event”), subject to certain conditions. This transaction, as well as proposed modifications to certain Constellation warrants, are subject to approval by Canopy
Resverlogix’ BETonMACE Phase 3 Trial Successfully Reaches its Targeted 250 MACE Events18.4.2019 14:00:00 CEST | Pressemelding
World’s First Phase 3 BET Bromodomain Epigenetics Trial Reaches Events Target CALGARY, Alberta, April 18, 2019 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) today announces that BETonMACE, the Company’s event-based, phase 3 registration trial has successfully reached 250 projected major adverse cardiac events (MACE), strictly defined as cardiovascular death, non-fatal myocardial infarction and stroke, moving the trial towards completion. Successful data from this trial would enable Resverlogix to proceed towards the regulatory approval and commercialization of its lead drug, apabetalone. “Resverlogix staff and stakeholders have worked diligently for the past 18 years to attain this extremely exciting goal,” said Donald McCaffrey, President and CEO of Resverlogix. “The trial’s extensive breakthrough clinical data will soon be available to Resverlogix. Successfully meeting the trial’s endpoints, the substantial data set and otherwise new findings would