Business Wire

Biogen Presents New Data from Long-Term Extension of Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab

Del

Biogen (NASDAQ: BIIB) will present new data from the long-term extension (LTE) of its ongoing Phase 1b study of aducanumab, the company’s investigational treatment for Alzheimer’s disease, at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting, Boston, November 1 – 4.

The data include results from patients in the Phase 1b study who were treated with a gradually increased dose of aducanumab for up to 24 months and those who were treated with a fixed dose of 3, 6 or 10 mg/kg aducanumab for up to 36 months. The results are consistent with previously reported analyses from the Phase 1b study and support the design of the ongoing Phase 3 studies of aducanumab for early Alzheimer’s disease.

“We now have up to three years of results from the Phase 1b study of aducanumab and during this time period we continued to observe reduction of the biomarker, amyloid plaque,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “The results also suggest there is a benefit on clinical decline for patients in the Phase 1b study, especially at the highest doses of aducanumab. Our Phase 3 studies of aducanumab are ongoing to determine whether it may be a potential treatment for early Alzheimer’s disease.”

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 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 in which patients received a gradually increased dose of aducanumab until they reach a maximum dose of 10 mg/kg.

The new analyses presented at CTAD include 143 patients in these groups:

  • Patients (n=18) initially randomized to titration dosing that gradually increased aducanumab from 1 to 3 to 6 then 10 mg/kg in the 54-week placebo-controlled period and treated up to 24 months
  • Patients (n=69) randomized to aducanumab 3, 6 or 10 mg/kg in the 54-week placebo-controlled period and treated up to 36 months
  • Patients (n=48) who were randomized to placebo or aducanumab 1 mg/kg in the 54-week placebo-controlled period who were switched to aducanumab 3 mg/kg or to a 3 to 6 mg/kg titration regimen in the LTE and treated up to 24 months
  • Patients (n=8) who were randomized to placebo in the 54-week placebo-controlled period who were switched to titration dosing that gradually increased their dose from 1 to 3 to 6 then 10 mg/kg 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 in the LTE 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.

24-Month Data
Patients who completed the 54-week, placebo-controlled period of the Phase 1b study had the option to continue in the LTE. Of the 196 patients who received placebo or aducanumab treatment in the placebo-controlled period of the Phase 1b study, 143 continued into the LTE. All patients who continued in the LTE were switched to or continued on aducanumab treatment.

Amyloid plaque levels were measured by positron emission tomography (PET) using the standardized uptake value ratio1 (SUVR) and continued to decline in those who remained on treatment for 24 months.

The Clinical Dementia Rating sum of boxes (CDR-SB) and the Mini-Mental State Examination (MMSE), which measure aspects of cognitive and physical function that can be affected by Alzheimer’s disease, were exploratory endpoints of the Phase 1b study. The results of these assessments suggest a continued benefit on the rate of clinical decline during the second year of treatment with aducanumab.

By 24 months, patients treated in the titration treatment group had an expected average dose of 7.6 mg/kg.

At 24 months, the mean change from amyloid plaque levels at the start of the Phase 1b study was:

  • -0.170 in those who switched from placebo to aducanumab treatment at 12 months
  • -0.149 in those who switched from 1 to 3 mg/kg at 12 months
  • -0.197 in the 3 mg/kg treatment group
  • -0.280 in the 6 mg/kg treatment group
  • -0.322 in the 10 mg/kg treatment group
  • -0.271 in the titration treatment group

At 24 months, the average decline from the start of the Phase 1b study on the CDR-SB was:

  • 3.25 points in those who switched from placebo to aducanumab treatment at 12 months
  • 3.52 points in those who switched from 1 to 3 mg/kg at 12 months
  • 2.32 points in the 3 mg/kg treatment group
  • 2.98 points in the 6 mg/kg treatment group
  • 1.69 points in the 10 mg/kg treatment group
  • 2.65 in the titration treatment group

At 24 months, the average decline from the start of the Phase 1b study on the MMSE was:

  • 4.28 points in those who switched from placebo to aducanumab treatment at 12 months
  • 3.65 points in those who switched from 1 to 3 mg/kg at 12 months
  • 2.81 points in the 3 mg/kg treatment group
  • 5.20 points in the 6 mg/kg treatment group
  • 1.97 points in the 10 mg/kg treatment group
  • 1.95 in the titration treatment group

36-Month Data
In patients treated up to 36 months, amyloid plaque as measured by PET using SUVR, continued to decrease in a dose- and time-dependent manner, with amyloid plaque levels in the 10 mg/kg fixed-dose treatment group reaching and remaining at a level considered below the quantitative cut-point that discriminates between a positive and negative scan.2

At 36 months, the mean change from amyloid plaque levels at the start of the Phase 1b study was:

  • -0.226 in those who switched from placebo to 3 mg/kg or 3-6 mg/kg aducanumab treatment at 12 months
  • -0.208 in those who switched from 1 to 3 mg/kg at 12 months
  • -0.243 in the 3 mg/kg treatment group
  • -0.286 in the 6 mg/kg treatment group
  • -0.306 in the 10 mg/kg treatment group

At 36 months, the average decline from the start of the Phase 1b study on the CDR-SB was:

  • 5.28 points in those who switched from placebo to 3 mg/kg or 3-6 mg/kg treatment at 12 months
  • 6.11 points in those who switched from 1 mg/kg to 3 mg/kg at 12 months
  • 3.86 points in the 3 mg/kg treatment group
  • 4.49 points in the 6 mg/kg treatment group
  • 2.84 points in the 10 mg/kg treatment group

At 36 months, the average decline from the start of the Phase 1b study on the MMSE was:

  • 7.98 points in those who switched from placebo to 3 mg/kg or 3-6 mg/kg treatment at 12 months
  • 6.35 points in those who switched from 1 mg/kg to 3 mg/kg at 12 months
  • 4.83 points in the 3 mg/kg treatment group
  • 8.97 points in the 6 mg/kg treatment group
  • 4.10 points in the 10 mg/kg treatment group

Data presentations for aducanumab at CTAD are scheduled for:

  • November 2, approximately 3:30 p.m. ET: Aducanumab 36-month data from PRIME: A randomized, double-blind, placebo-controlled Phase 1b study in patients with prodromal or mild Alzheimer’s disease
  • November 4, approximately 11:15 a.m. ET: Aducanumab titration dosing regimen: 24-month analysis from PRIME: A randomized, double-blind, placebo-controlled Phase 1b study in patients with prodromal or mild Alzheimer’s disease

These data presentations will be webcast live. To access the live webcasts, please visit the Investors section of Biogen’s website at www.biogen.com/investors. An archived version of the webcasts will be available following the presentation.

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 compound being developed for the treatment of 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 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.

As of October 2017, Biogen and Eisai entered into a global collaboration agreement to jointly develop and commercialize aducanumab.

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 worldwide.3 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
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. Founded in 1978 as one of the world’s first global biotechnology companies by Charles Weissman and Nobel Prize winners Walter Gilbert and Phillip Sharp, today Biogen 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. 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.

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, and the potential clinical effects of aducanumab. These statements may be identified by words such as “anticipate,” "believe," “could,” “estimate,” "expect," “forecast,” “intend,” "may," "plan," "potential," “possible,” "will," and other words and terms of similar meaning, and are based on our current beliefs and expectations. You should not place undue reliance on these statements or the scientific data presented. 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. 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 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. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our 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 our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

1 A composite standardized uptake value ratio (SUVR) of six regions of the brain – frontal, parietal, lateral temporal, sensorimotor, anterior and posterior cingulate – was calculated at baseline, at 26, 54, 110 and 166 weeks using whole cerebellum as a reference.

2 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.

3 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 CONTACT:
Matt Fearer, +1 781-464-3260
public.affairs@biogen.com
or
INVESTOR CONTACT:
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

Tan Delta: New Oil Condition Monitoring Kit for Gas Engine Operators Reduces Daily Operating Costs, Improves Equipment Efficiency and Extends Equipment Life.23.11.2017 13:38Pressemelding

The new Gas Engine oil condition monitoring kit from Tan Delta Systems can be quickly and easily fitted to any gas engine and enables the oil to be monitored and tracked continuously in real time enabling significantly reduced maintenance costs, increased equipment efficiency and extended equipment life. Operators can expect their investment returned in under four months followed by many years of net financial and operational benefits. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171123005177/en/ Gas Engine Oil Condition Monitoring (Photo: Business Wire) The kit includes everything needed for quick and easy installation on any gas engine operating in any environment. No more need for expensive laboratory oil testing. Reduce daily operating costs by optimising maintenance schedules. Protect a

Making Institut Curie a Reference for Technology Transfer in Oncology23.11.2017 13:00Pressemelding

Institut Curie has adopted an ambitious strategy for technology transfer and partnerships with innovative companies. This new dynamic, initiated within the framework of the 2015-2020 MC21 strategic plan (Marie Curie in the 21 st century), aims at positioning the Institut Curie as a reference for technology transfer in oncology. The strategy ambition to better accompany Institut Curie researchers and physicians in the protection, development and commercialization of their inventions, and reinforces support for the setting-up of collaborations with innovative companies. "The objective is to optimize the identification, promotion and transfer of all the scientific, technological and medical resources of the Institute in an open innovative approach" says Amaury Martin, Executive Director of Institut Curie Technology Transfer

Wealth Dynamix (WDX) Ranks No.18 in the 2017 Tech Track 100 by the Sunday Times and 19th Fastest Growing Technology Company in the UK in the 2017 Deloitte Technology Fast 5023.11.2017 08:00Pressemelding

WDX ranks No.18 in the 17th annual Sunday Times Hiscox Tech Track 100 league table league which consisted of the top 100 private technology, media and telecoms (TMT) companies in Britain. WDX recorded a 155% average annual sales growth per year over the last 3 years with sales reaching £6.4M in September 2016 and £9m by end of September 2017. More recently, in November 2017, WDX also announces ranking No.19 in the 2017 Deloitte UK Technology Fast 50, a ranking of the 50 fastest growing technology companies in the UK. Rankings are based on percentage revenue growth over the last four years of which, WDX grew 1,563% during this period. WDX attributed this revenue growth to the team’s hard work and the positive change in attitude toward technology in the Wealth and Investment Management industry. WDX’s CEO, Gary Linieres credits the team with the company’s revenue growth. He sa

Mobidiag Signs Agreement with Interlux for the Distribution of Amplidiag® Diagnostic Tests and Instruments in Estonia23.11.2017 07:00Pressemelding

Mobidiag Ltd, a Finnish molecular diagnostics company, today announced a distribution agreement with Interlux OÜ, supplier of technologies for medicine, science and biotechnology industry. Under this agreement, Interlux becomes the exclusive distributor of the Amplidiag® product line in Estonia, in vitro diagnostic tests and compatible instrument for the detection of gastrointestinal infections. “Thanks to a large distribution network, our Amplidiag product line is now accessible in most Western European countries. This new distribution agreement allows us to introduce the Amplidiag product line to the Baltic region starting with Estonia. We are then very happy to start this new partnership with Interlux to support us in this new market”, said Miquel Vernet, CCO at Mobidiag. “Cooperation with Mobidiag offers the customers of Interlux high-quality diagnostic results. I believ

OCP Announces Date of 2017 Third Quarter and Nine Month Results22.11.2017 16:59Pressemelding

OCP S.A., a global leader in the fertilizer industry, will release its third quarter and nine month 2017 results on Thursday, November 30, 2017. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal at 9 a.m. EDT and 2 p.m. Morocco/London time. OCP senior management will host a conference call to discuss 2017 third quarter/nine month results at 10 a.m. EDT and 3 p.m. Morocco/London time on Thursday, November 30, 2017 for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing g.laraki@ocpgroup.ma. About OCP OCP is a global leader in the fert

Tata Motors Charts Out 'Connecting Aspirations' As Its New Corporate Brand Identity in Global Markets22.11.2017 14:46Pressemelding

As part of the company’s transformation journey undertaken in 2016, Tata Motors commenced a comprehensive project to articulate its corporate branding. Basis a thorough analysis of the existing and the desired future state of the Company, Tata Motors has defined its new brand identity as ‘Connecting Aspirations’ across 46 markets, internationally. ‘Connecting Aspirations’, as the new defining maxim, represents the personality of the brand as an interconnected system of mobility solutions, that are intelligent, perceptive, warm and expressive. It’s a symbolic tagline that represents the company’s past, present and future. It is humble yet bold, a statement as well as a challenge. It will define the way Tata Motors communicates with its internal as well as external stakeholders, and work as an all-encompassing guiding principle across business units.” Speaking on the

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

Besøk vårt presserom