GlobeNewswire

Biogen and Eisai Announce Presentation of Detailed Analyses from the Phase 1b Long-Term Extension Study of Aducanumab at Clinical Trials on Alzheimer’s Disease (CTAD)

Del

Three- and four-year data continued to show reduction in amyloid plaque and to suggest a slowing of the rate of clinical decline in patients

CAMBRIDGE, Mass., Oct. 26, 2018 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that Biogen presented results at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting, in Barcelona, Spain, from the recent 36- and 48-month analyses of the ongoing long-term extension (LTE) of the Phase 1b study of aducanumab, an investigational treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD.

A late-breaking oral presentation and a poster included data from patients treated with aducanumab for up to 36 and 48 months. Data from both analyses showed a reduction in amyloid plaque levels in a dose- and time-dependent manner, as measured by positron emission tomography (PET). In addition, analyses of exploratory clinical endpoints, Clinical Dementia Rating Sum of Boxes (CDR-SB) and the Mini-Mental State Examination (MMSE), suggested a continued slowing of clinical decline over 36 months and 48 months. The results in each dosing arm were generally consistent with previously reported analyses of this study, and there were no changes to the risk-benefit profile of aducanumab.

“This Phase 1b study now has four years of aducanumab results, and we are encouraged by these data, which continued to show a reduction in amyloid plaque levels and suggest our investigational therapy may slow clinical progression of the disease,” said Alfred Sandrock, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen. “The Phase 3 studies are now fully enrolled, and we remain driven by the profound unmet needs of patients, families, caregivers and society.”

About the Phase 1b Study
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 primary endpoint for the study was safety. Other endpoints (amyloid reduction, CDR-SB and MMSE) were exploratory.

The study included fixed dosing at 1, 3, 6 and 10 mg/kg as well as an arm with a titration regimen up to 10 mg/kg in a cohort of ApoE ε4 carriers only.  

In the Phase 1b study, 196 patients received aducanumab or placebo, of which 143 entered the LTE. All patients who continued in the LTE were switched to, or continued on, aducanumab treatment. The LTE cohorts were allocated across six dosing arms including: placebo switchers (n=37), 1 mg/kg switchers to 3 mg/kg (n=19), fixed doses (3 mg/kg [n=26], 6 mg/kg [n=24], 10 mg/kg [n=19]) and titration (n=18). There were discontinuations, as expected in studies of 36 or more months. As a result, there are smaller patient numbers in the LTE over time.

Of the 185 patients dosed with aducanumab in the Phase 1b study, 46 patients experienced amyloid-related 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, clinically asymptomatic and resolved or stabilized within 4-12 weeks, with most patients continuing treatment. In the Phase 1b study, the most commonly reported adverse events were headache, fall and ARIA. There were no new incident cases of ARIA-E since the last interim analysis.

36-Month Data
Amyloid plaque levels were measured by PET using the standardized uptake value ratio (SUVR), and continued to decline in those who remained on treatment for 36 months. Amyloid plaque levels in the 10 mg/kg fixed dose at 36 months remained at a level considered below the quantitative cut-point that discriminates between a positive and negative scan.

The exploratory endpoints, CDR-SB and the MMSE, measure cognitive and functional decline associated with AD. The results of these assessments suggest a continued slowing of clinical decline during the third year of treatment with aducanumab in certain groups. 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.

The expected average dose for the titration cohort at 36 months was 8.4 mg/kg.

At 36 months, a reduction of amyloid plaque (versus placebo) was observed in all fixed-dose and titration arms in a dose- and time-dependent manner. The changes in amyloid plaque, CDR-SB and MMSE are detailed below.

At 36 months from the start of the Phase 1b study: Adjusted Mean
Change from
Baseline in
Amyloid PET
SUVR*
Adjusted Mean
Change from
Baseline in
CDR-SB
Adjusted Mean
Change from
Baseline in
MMSE
Placebo switchers to aducanumab -0.248 4.83 -6.75
Switchers from 1 to 3 mg/kg -0.198 6.21 -6.24
3 mg/kg treatment group -0.241 3.86 -4.98
6 mg/kg treatment group -0.278 4.50 -9.07
10 mg/kg treatment group -0.301 2.87 -4.23
Titration treatment group -0.308 3.10 -4.28
* Parameter: Amyloid PET composite ROI SUVR measure (Reference Region = cerebellum)
 

48-Month Data
In patients treated up to 48 months, amyloid plaque continued to decrease in a dose- and time-dependent manner. 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. The changes in amyloid plaque, CDR-SB and MMSE are detailed below.

At 48 months from the start of the Phase 1b study: Adjusted Mean
Change from
Baseline in
Amyloid PET
SUVR*
Adjusted Mean
Change from
Baseline in
CDR-SB
Adjusted Mean
Change from
Baseline in
MMSE
Placebo switchers to aducanumab -0.260 6.95 -10.24
Switchers from 1 to 3 mg/kg -0.232 8.44 -9.49
3 mg/kg treatment group -0.261 5.57 -8.22
6 mg/kg treatment group -0.324 7.75 -12.62
10 mg/kg treatment group -0.340 3.87 -4.82
* Parameter: Amyloid PET composite ROI SUVR measure (Reference Region = cerebellum)
       

Phase 3 Studies
In July 2018, enrollment was completed for the Phase 3 aducanumab ENGAGE and EMERGE studies, designed to evaluate the efficacy and safety of aducanumab in slowing cognitive and functional impairment in people with early Alzheimer’s disease.

About Aducanumab
Aducanumab (BIIB037) is an investigational compound being studied for the treatment of early Alzheimer’s disease. Biogen licensed aducanumab from Neurimmune under a collaboration and license agreement. Aducanumab is a human 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). As of October 2017, Biogen and Eisai Co., Ltd. are collaborating on the development and commercialization of aducanumab globally.

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; the treatment of AD; 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.

 
Contacts
MEDIA CONTACT:
Biogen Inc.
David Caouette
+1-617-679-4945
public.affairs@biogen.com
MEDIA CONTACT:
Eisai Co., Ltd.
Public Relations Department
TEL: +81-(0)3-3817-5120
Eisai Inc.
Public Relations Department
TEL: +1-551-262-2686
   
INVESTOR CONTACT:
Biogen Inc.
Matt Calistri
+1-781-464-2442
IR@biogen.com 
INVESTOR CONTACT:
Eisai Co., Ltd.
Investor Relations Department
TEL: +81-(0)3-3817-5327

 

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

Fortuna reports 2018 full year production of 12.8 million silver equivalent ounces and issues 2019 guidance17.1.2019 11:00Pressemelding

VANCOUVER, British Columbia, Jan. 17, 2019 (GLOBE NEWSWIRE) -- Fortuna Silver Mines, Inc. (NYSE: FSM) (TSX: FVI) is pleased to announce fourth quarter and full year 2018 production figures from its two underground operating mines, the San Jose Mine in Mexico and the Caylloma Mine in Peru. For the full year 2018, the Company produced 8.9 million ounces of silver and 54.2 thousand ounces of gold or 12.8 million Ag Eq1 ounces. 2018 Consolidated Production Highlights Silver and gold production were 7 % and 12 % respectively above 2018 guidance Silver production of 8,890,943 ounces; 5 % increase over 2017 Gold production of 54,210 ounces; 4 % decrease over 2017 Zinc production of 45,484,648 pounds; 3 % increase over 2017 Lead production of 28,254,570 pounds; 5 % decrease over 2017 2018 Consolidated Operating Results Q4 2018 2018 Caylloma, Peru San Jose, Mexico Consolidated Caylloma, Peru San Jose, Mexico Consolidated Processed Ore Tonnes milled 135,034 256,181 534,773 1,040,478 Average tpd

WillScot to Participate at the Barclays Industrial Select Conference16.1.2019 21:00Pressemelding

BALTIMORE, Jan. 16, 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 present at the Barclays Industrial Select Conference at the Loews Miami Beach Hotel in Miami, Florida, on Wednesday, Feb. 20, 2019. The presentation will take place at 10:20 a.m. EST. About Williams Scotsman Headquartered in Baltimore, Maryland, WillScot Corporation is the public holding company for the WillScot family of companies in the United States, Canada and Mexico. WillScot Corporation trades on the NASDAQ stock exchange under the ticker symbol “WSC.” WillScot is the specialty rental services market leader providing innovative modular space and portable storage solutions across North America. It is the modular space supplier of choice for t

CCI has been retained by Waterloo Brewing to obtain Cannabis Licence16.1.2019 16:00Pressemelding

TORONTO, Jan. 16, 2019 (GLOBE NEWSWIRE) -- Cannabis Compliance Inc., (CCI) of Toronto, Ontario is pleased to announce they have partnered with Waterloo Brewing to help them obtain their Research and standard Processing Licence to develop cannabis-infused beverages. “CCI is working with Waterloo Brewing on the early stages of the application process and we are confident that we will help them achieve their desired licenses in time to be an active player in this growing sector of the cannabis industry”, said Brian Wagner, CEO and Founder, Cannabis Compliance Inc. “We are here to guide our clients through the early stages of the licensing process and for the many Health Canada requirements thereafter.” CCI offers end to end business solutions for cannabis companies large and small. Our team brings with them years of experience in the quality, regulatory, security and cultivation sectors, and supports manufacturers and retailers through regulatory challenges. As the world’s largest and mos

Aryaka Announces Expansion of Senior Leadership Team with New Chief Revenue Officer, Chief Transformation Officer and Chief Marketing Officer16.1.2019 15:00Pressemelding

Karen Freitag, Michelle Owczarzak, & Shashi Kiran join Aryaka to address significant growth and assist global enterprises in adopting managed connectivity as-a-service SAN MATEO, Calif., Jan. 16, 2019 (GLOBE NEWSWIRE) -- Aryaka®, announced today the appointment of several new executive hires to the company’s leadership team, including Karen Freitag (Chief Revenue Officer), Michelle Owczarzak (Chief Transformation Officer), and Shashi Kiran (Chief Marketing Officer). “Connectivity is the lifeblood of the global enterprise and Aryaka is the industry benchmark for secure managed connectivity worldwide. We are excited to have experienced industry veterans join our robust executive leadership team and continue to help build upon the immense success and growth that Aryaka has seen in recent years,” said Matt Carter, CEO of Aryaka. “As our customers expand globally, embrace SD-WAN, or move to the cloud, we’re becoming the de facto choice for their needs to make this happen better, faster, che

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