Results Support Design of Ongoing Phase 3
Studies of Aducanumab for Early Alzheimer’s Disease
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 ExtensionPatients 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 StudiesAducanumab 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 AducanumabAducanumab (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 DiseaseAlzheimer’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 BiogenThrough 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 HarborThis 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.
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BiogenMEDIA:Catherine Falcetti,
+1-781-464-3260public.affairs@biogen.comorINVESTORS:Matt Calistri,
+1-781-464-2442IR@biogen.com
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