GlobeNewswire

Biogen and Eisai Report Data from Long-Term Extension Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab

Del

Data Includes Additional Analyses of Long-Term Extension Phase 1b Study With Titration Cohort at 36 Months and Fixed-Dose Cohorts at 48 Months

CAMBRIDGE, Mass., Aug. 28, 2018 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced results from a recent analysis of the ongoing long-term extension (LTE) Phase 1b study of aducanumab, an investigational treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. The updated analyses include data from the placebo-controlled period and LTE for patients treated with aducanumab up to 36 months in the titration cohort and up to 48 months in the fixed-dose cohorts. The results are generally consistent with previous interim analyses, and there were no changes to the risk-benefit profile of aducanumab.

The Phase 1b study is a randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical effects of aducanumab in patients with prodromal AD or mild AD dementia. The study includes fixed dosing at 1, 3, 6 and 10 mg/kg as well as an arm with a titration regimen in which patients received a gradually increased dose of aducanumab until they reach a maximum dose of 10 mg/kg.

In the Phase 1b study 196 patients received aducanumab or placebo, of which 143 patients entered the LTE.  The LTE cohorts were allocated across six dosing arms including:  placebo switchers, 1 mg/kg switchers to 3 mg/kg, fixed doses (3 mg/kg, 6 mg/kg, 10 mg/kg) and titration. Additionally, there were discontinuations as expected in studies of 36 or more months. As a result, there are small patient numbers in the new analyses.

The results for each dose arm are generally consistent with previous interim analyses. Amyloid plaque levels as measured by positron emission tomography (PET) continued to decrease in a dose- and time-dependent manner in patients from the titration cohort at 36 months and fixed-dose cohorts at 48 months. Amyloid plaque levels in the 10 mg/kg fixed-dose at 48 months remained at a level considered below the quantitative cut point that discriminates between a positive and negative scan. Analyses of exploratory clinical endpoints Clinical Dementia Rating Sum of Boxes (CDR-SB) and the Mini-Mental State Examination (MMSE) suggest a continued benefit on the rate of clinical decline over 36 months and 48 months, respectively. Clinical effects with titrated aducanumab in the second year of the LTE were generally consistent with findings in the 10 mg/kg fixed-dose cohorts.

Of the 185 patients dosed with aducanumab in the Phase 1b study, 46 patients experienced amyloid imaging abnormalities (ARIA)-E (edema). Eight patients experienced more than one episode of ARIA-E. The majority of ARIA events occurred early in the course of treatment; they were typically mild radiographically (MRI), clinically asymptomatic and resolved or stabilized within 4-12 weeks, with most patients continuing treatment. In the Phase 1b LTE, the most commonly reported adverse events were headache, fall and ARIA.

Detailed results of the study will be presented at upcoming medical conferences.

About Aducanumab
Aducanumab (BIIB037) is an investigational compound being studied for the treatment of early Alzheimer’s disease. Aducanumab is a human recombinant monoclonal antibody (mAb) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen licensed aducanumab from Neurimmune under a collaboration and license agreement. As of October 22, 2017, Biogen and Eisai Co. Ltd. are collaborating on the development and commercialization of aducanumab globally.

About the Joint Development Agreement between Biogen and Eisai for Alzheimer’s Disease
Eisai and Biogen are widely collaborating on the joint development and commercialization of Alzheimer’s disease treatments. Biogen serves as the lead for co-development of aducanumab, Biogen’s investigational anti-amyloid beta (Aβ) antibody for patients with Alzheimer’s disease which Eisai has been co-developing since October 22, 2017.  Eisai serves as the lead in the co-development of elenbecestat, a BACE inhibitor, and BAN2401, an anti-amyloid beta (Aβ) protofibril antibody, 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.

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, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.

We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

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 https://www.eisai.com.

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 about additional results from the Phase 1b study of aducanumab; the potential clinical effects of aducanumab; the potential benefits, safety and efficacy of aducanumab; and risks and uncertainties associated with drug development and commercialization. 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 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, 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 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 aducanumab; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; 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.

MEDIA CONTACT: INVESTOR CONTACT:
   
David Caouette  
+1 617 679 4945
public.affairs@biogen.com
Matt Calistri
+1 781 464 2442 
IR@biogen.com

Om GlobeNewswire

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

https://globenewswire.com

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

ADC Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ADCT-601 in Advanced Solid Tumors16.1.2019 07:00Pressemelding

Pyrrolobenzodiazepine-based antibody drug conjugate targets AXL, a receptor tyrosine kinase highly expressed in solid tumors LAUSANNE, Switzerland, Jan. 16, 2019 (GLOBE NEWSWIRE) -- ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), today announced that the first patient has been dosed in its Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-601 in patients with selected solid tumors that are locally advanced or metastatic. ADCT-601 is an ADC composed of a humanized monoclonal antibody against human AXL, conjugated using GlycoConnect™ site specific conjugation technology to a pyrrolobenzodiazepine (PBD) dimer toxin. In preclinical studies, ADCT-601 demonstrated potent and specific in vitro and in vivo anti-tumor activity in multiple cancer-derived models with different levels of AXL expression, and was stable and well tolerated

GSA Europe’s Managing Director Elected Co-lead of CEN’s TC456 Committee15.1.2019 21:12Pressemelding

SAN GWANN, Malta, Jan. 15, 2019 (GLOBE NEWSWIRE) -- GSA Europe’s Managing Director Mark Pace has been elected by the Comité Européen de Normalisation (CEN) to lead the creation of a European Union online gaming reporting standard. CEN has established Technical Committee 456 to create this standard in support of online gambling supervision. GSA Europe joined Technical Committee 456 as a Liaison Organization in 2017. The Technical Committee’s mandate from the European Commission is directly aligned with work that GSA Europe has already started, namely, to create a single standard set of data elements and single standard way in which data is provided by online gambling providers to EU Member State regulatory authorities. In addition to joining and now leading the Technical Committee’s work, GSA Europe also donated their draft Regulatory Data Set and Regulatory Reporting Interface to CEN seeking to help jump-start the Committee’s work. “Joining CEN’s TC456 as a Liaison Organization, and no

Orion Biotechnology Reports Positive Results for Colorectal Cancer in Preclinical Study15.1.2019 15:00Pressemelding

OTTAWA, Jan. 15, 2019 (GLOBE NEWSWIRE) -- Orion Biotechnology Canada Ltd., a developer of novel medical treatments, today announced preclinical data produced in collaboration with Charles River Laboratories, evaluating the efficacy of OB-002O (5P12-RANTES) in colorectal cancer. BALB/c mice were inoculated subcutaneously with the CT-26 colorectal cancer cell line. Three days after inoculation intraperitoneal treatment was started with OB-002O, a murine anti-PD-1 antibody, OB-002 + anti-PD-1, or saline placebo. Treatment was given daily or every third day. Treatment with OB-0020 alone led to statistically significant delayed tumor growth at multiple time-points. An even more profound effect on the decrease in mean tumor volume was observed in combination cohort where animals received both, OB-0020 and the anti-PD-1 antibody (p>0.05). “There is growing awareness of the role of CCR5 antagonism as an important component of cancer immunotherapy. OB-002O is an extremely potent CCR5 antagonist

Credit Suisse Partners with CGAP on Digital Finance to Catalyze Delivery of Energy, Water and other Services to Low Income People15.1.2019 14:08Pressemelding

Washington/Zurich, Jan. 15, 2019 (GLOBE NEWSWIRE) -- Credit Suisse, one of the world's leading financial services providers, is partnering with the Consultative Group to Assist the Poor (CGAP) to support its work in building inclusive and responsible financial systems that help people move out of poverty, protect their economic gains and advance the broader global development agenda. CGAP is a global partnership of more than 30 leading development agencies, private foundations and national governments committed to financial inclusion as a means toward expanding opportunities for poor people. Through their engagement, CGAP and Credit Suisse will capitalize upon and leverage each other’s knowledge to further financial inclusion and its contribution toward achieving the United Nations’ Sustainable Development Goals (SDGs). Among the projects that align well with Credit Suisse’s expertise are CGAP’s work on sustainable business models that use digital finance technologies to lower the cost

TrueCommerce Recognized as a Leader in IDC MarketScape for Worldwide Multi-Enterprise Supply Chain Commerce Network15.1.2019 14:00Pressemelding

-- “The vendor offers a true partnership for their customers and has become an extension of their internal staff and resources to manage their supply chains,” says the report -- PITTSBURGH, Jan. 15, 2019 (GLOBE NEWSWIRE) -- TrueCommerce, a global provider of trading partner connectivity, integration and unified commerce solutions , has announced today it was positioned in the Leaders category of the IDC MarketScape for Worldwide Multi-Enterprise Supply Chain Commerce Network report. The research states that TrueCommerce offers a broad set of supply chain applications that extend far beyond traditional data transportation. “Our investments into the cutting-edge unified commerce technology and customer care allowed the company to make this qualitative leap, and we are proud to be recognized by such a reputable global research firm as IDC,” said TrueCommerce president Ross Elliott. “The report advises companies to engage with a network vendor that is at least thinking about what tomorrow

UnionBank Launches First Fully Digital Branch in the Philippines15.1.2019 13:30Pressemelding

Appian Cloud Platform Enables Low-Code Rapid Application Development for Powerful Process Automation RESTON, Va. and SYDNEY, Australia , Jan. 15, 2019 (GLOBE NEWSWIRE) -- Appian (NASDAQ: APPN) announces that UnionBank of the Philippines used the Appian Platform to launch its first fully digital branch. The branch, called The Ark, completely transforms the customer experience, making that experience entirely digital, including internet-connected self-service kiosks and virtual reality boxes. Unlike traditional bank branches, The Ark has done away with rows of tellers and long queues, and gone completely paperless. Customers now go to one of the self-service iPad stands stationed around the bank, where they can type in their request, significantly reducing time previously spent waiting in queues for service. “The Ark is an award-winning digital branch that provides a modern experience for our clients within a traditional brick and mortar store,” said Anna Maria Aboitiz Delgado, Head for