Business Wire

Biogen Reports New Data from Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab

Del

Biogen (NASDAQ: BIIB) today announced results from a recently conducted analysis of the long-term extension (LTE) of its ongoing Phase 1b study of aducanumab, the company’s investigational treatment for early Alzheimer’s disease.

The updated analyses include data from the placebo-controlled period and LTE for patients treated with aducanumab up to 24 months in the titration cohort and up to 36 months in the fixed-dose cohorts. The results are consistent with previously reported analyses from this ongoing Phase 1b study and support the design of the ongoing Phase 3 studies of aducanumab for early Alzheimer’s disease.

The Phase 1b 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 or mild Alzheimer’s disease. The study includes fixed dosing at 1, 3, 6 and 10 mg/kg as well as an arm with a titration regimen.

Phase 1b Long-Term Extension
Patients who completed the 54-week, placebo-controlled period of the Phase 1b study had the option to continue in the LTE.

The new analyses include 143 patients who remained in the LTE. The LTE cohorts are small populations:

  • Patients (n=18) initially randomized to the aducanumab titration regimen in the 12-month placebo-controlled period and treated up to 24 months
  • Patients (n=69) initially randomized to aducanumab 3, 6 or 10 mg/kg and treated up to 36 months
  • Patients (n=48) who were randomized to placebo or aducanumab 1 mg/kg in the placebo-controlled period who were switched to aducanumab 3 mg/kg or to a 3-6 mg/kg titration regimen in the LTE and treated up to 24 months
  • Patients (n=8) who were randomized to placebo in the placebo-controlled period who were switched to aducanumab 1-3-6-10 mg/kg titration regimen in the LTE and treated up to 12 months

In the Phase 1b LTE, the most commonly reported adverse events were headache, fall and amyloid-related imaging abnormalities (ARIA). Of the 185 patients dosed with aducanumab in the Phase 1b study, 46 patients experienced ARIA-E (edema). There were no new cases of ARIA-E in patients who continued on the same dose of aducanumab. The incidence of ARIA-E in patients switching from placebo to aducanumab was consistent with the incidence reported in the placebo-controlled portion of the Phase 1b study. Six patients experienced more than one episode of ARIA-E. These recurrent events were consistent with other ARIA events reported to date; they were typically asymptomatic, and most patients continued in the study.

In patients treated up to 24 months in the titration cohort, amyloid plaque reduction as measured by positron emission tomography (PET) was consistent with the dose- and time-dependent results observed in the fixed-dose cohorts. Analyses of exploratory clinical endpoints, Clinical Dementia Rating sum of boxes (CDR-SB) and the Mini-Mental State Examination (MMSE), were consistent with the results from the fixed-dose cohorts and suggest a continued benefit on the rate of clinical decline during the second year of treatment.

In patients treated up to 36 months, amyloid plaque as measured by PET continued to decrease in a dose- and time-dependent manner, with amyloid plaque levels in the 10 mg/kg fixed-dose cohort reaching and remaining at a level considered below the quantitative cut-point that discriminates between a positive and negative scan1. At 36 months, analyses of exploratory clinical endpoints CDR-SB and the MMSE suggest a continued benefit on the rate of clinical decline during the third year of treatment.

Biogen plans to share more data from these analyses at an upcoming medical congress.

Phase 3 Clinical Studies
Aducanumab is currently being evaluated in two global Phase 3 studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease.

For more information about the Phase 3 studies, including information about participating centers, visit www.ClinicalTrials.gov (NCT02477800 or NCT02484547).

About Aducanumab
Aducanumab (BIIB037) is an investigational drug being developed for the treatment of early AD. 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 collaborative development and license agreement.

Aducanumab is thought to target aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils which can form into amyloid plaque in the brain of AD patients. Based on pre-clinical and Phase 1b data to date, treatment with aducanumab has been shown to reduce amyloid plaque levels.

In August 2016 aducanumab was accepted into the European Medicines Agency’s PRIME program. In September 2016 the U.S. Food and Drug Administration accepted aducanumab into its Fast Track program and in April 2017 aducanumab was accepted into the Japanese Ministry of Health, Labour and Welfare’s (MHLW) Sakigake Designation System.

About Alzheimer’s Disease
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder characterized by cognitive decline and behavioral disturbances that eventually result in a person’s inability to perform daily activities. In 2010, it was estimated that 25 million individuals were living with AD worldwide2. Evidence suggests that pathophysiological changes typically begin years prior to the symptoms that lead to a clinical diagnosis. As the disease progresses, cognitive impairments, behavioral changes and functional disability commonly associated with AD begin to manifest.

About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology, and today the company has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

Biogen Safe Harbor
This press release contains forward-looking statements, including statements about additional results from the phase 1b study, and the potential clinical effects of aducanumab. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. 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. Factors which could cause actual results to differ materially from our current expectations include the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected, unexpected concerns may arise from additional data, analysis or results obtained during our clinical trials, regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, the occurrence of adverse safety events, or we may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements.

1 Landau, S. M., Mintun, M. A., Joshi, A. D., Koeppe, R. A., Petersen, R. C., Aisen, P. S., Weiner, M. W., Jagust, W. J. and for the Alzheimer's Disease Neuroimaging Initiative (2012), Amyloid deposition, hypometabolism, and longitudinal cognitive decline. Ann Neurol., 72: 578–586. doi:10.1002/ana.23650.
2 World Health Organization Dementia a Public Health Priority. http://www.who.int/mental_health/publications/dementia_report_2012/en/. Accessed 23 May 2016.

Contact information

Biogen
MEDIA:
Catherine Falcetti, +1-781-464-3260
public.affairs@biogen.com
or
INVESTORS:
Matt Calistri, +1-781-464-2442
IR@biogen.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

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

Siste saker fra Business Wire

Integral Expands Cryptocurrency Market Data Services to Include 14 Cryptocurrencies and 16 Exchanges23.1.2018 22:00Pressemelding

Integral (www.integral.com), the financial technology partner trusted by leading banks, brokers, and investment managers to design, deliver and grow their FX businesses, announced today that it has expanded its market data offering for cryptocurrencies to include 14 major cryptocurrencies connecting to all major exchange sources across the U.S., Europe and Asia including Japan and Hong Kong. “An accurate, stable, and reliable reference price is a requirement for any market maker,” said Harpal Sandhu, CEO of Integral. “The Cryptocurrency Market Data Service connects to the most price sources and applies the most advanced price discovery algorithm available.” Integral has years of experience as a technology leader and innovator in foreign exchange and is now applying this ingenuity to the cryptocurrency market. The Market Data Service uses algorithms developed with Stanford University for Integral FX Benchmark to provide the most precise reference prices for cryptocurrencies. “Integral’s

Kimbal Riley to Become Vista Group CEO23.1.2018 21:57Pressemelding

Vista Group International (NZX & ASX: VGL) has today announced that Kimbal Riley will take over as Group CEO from Murray Holdaway. Mr Holdaway will take up the position of Chief Product Officer (CPO) for Vista Group, and will continue in his role as an Executive Director on the Vista Group board. This has taken place as part of a succession planning process and will deliver a seamless transition within the business. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123006545/en/ Kimbal Riley becomes CEO of Vista Group International (Photo: Business Wire) Mr Riley has had an extensive career in senior executive roles in the IT and Services industries in New Zealand and overseas. He joined Vista Group four years ago, with the past two years as CEO of Vista Entertainment Solutions (VES), which is responsible for the largest proportion of the Group’s revenue. He has been focused on building scale in the business and under his lea

IFF Breaks Ground on Flavors/Fragrances Site in Sri City, India23.1.2018 17:00Pressemelding

Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF), a leading innovator of sensory experiences that move the world, has broken ground on a new flavors and fragrances plant located in Sri City, in the State of Andhra Pradesh in India. Part of a larger investment into the Greater Asia region, the plant is expected to be commercialized in December 2019. The new facility, which will be the largest flavor and fragrance manufacturing facility in India and the largest IFF site in Greater Asia, occupies a 32-acre/130,000m2 plot and will serve IFF flavors and fragrances customers across India and the region. “In this economically vibrant country, it is critical that we invest to provide our customers with winning tastes and scents,” said IFF Chairman and CEO Andreas Fibig. “This new facility is fitted with capabilities tailored for our customers’ needs. Coupled with our excellent consumer insights teams and their deep understanding of the local markets, w

Global Eagle to Elevate Airline Passenger Experience Over North America with More SES HTS Satellite Capacity23.1.2018 14:33Pressemelding

Global Eagle Entertainment Inc. (NASDAQ: ENT) is aiming to provide airline passengers travelling across North America with a connected inflight experience far more like the one passengers enjoy on the ground, tripling the amount of high throughput satellite (HTS) capacity secured with SES Networks aboard the SES-15 satellite. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123005989/en/ Global Eagle to Elevate Airline Passenger Experience Over North America with More SES HTS Satellite Capacity (Photo: Business Wire) SES announced today that Global Eagle has secured a major increase of Ku-band capacity on its new hybrid SES-15 HTS satellite to enable the delivery of high-speed broadband and a wide range of inflight communications and operational applications aboard commercial airline flights throughout the US, including the increasingly important US mainland to Hawaii routes. The multi-year agreement is the latest contract t

Optiv Security Names Simon Church as General Manager and Executive Vice President, Europe; Accelerates International Growth Strategy with Expansion in Europe23.1.2018 14:05Pressemelding

Optiv Security, a market-leading provider of end-to-end cyber security solutions, today announced it is continuing to accelerate its international growth strategy by naming Simon Church as general manager and executive vice president, Europe. In his newly created role, Church will establish and grow Optiv’s presence in Europe, enabling the company to serve locally-based organizations and global clients with expanded skills, knowledge and presence. Optiv serves more than 60% of the Fortune 1000, and this appointment will increase its ability to provide US and international clients with worldwide expertise and experience, assisting them in reducing the complexity of their cyber security programs while maximizing the efficacy and value of their security investments. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123005315/en/ Optiv Security Names Simon Church as General Manager and Executive Vice President, Europe; Accelerate

LEGO® Education Launches New Maker Activities for Schools23.1.2018 14:00Pressemelding

LEGO® Education Maker, a continuum of activities for early learning through middle school, is available today to schools around the world. The activities are centered around the iconic LEGO brick and inspired by the open-ended, playful creativity of making. The new, free LEGO Education Maker activities include stimulating challenges for every student at every education level and incorporate LEGO Education solutions including LEGO Education STEAM Park, LEGO Education Simple Machines, LEGO Education WeDo 2.0, LEGO® MINDSTORMS® Education EV3 and LEGO Education Simple and Powered Machines. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123005927/en/ LEGO® Education Launches New Maker Activities for Schools (Photo: Business Wire) New LEGO Education Maker activities provide unlimited learning for all ages The new LEGO Education Maker activities place educators in the role of facilitators, as they guide their students through a s

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

Besøk vårt presserom