Eisai Alzheimer's Disease Pipeline Research to be Presented at Virtual AAIC 2020, Including BAN2401 and Lemborexant Data and a Biomarker Symposium
WOODCLIFF LAKE, N.J., July 24, 2020 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today the presentation of new data and information from the company's robust AD pipeline, including BAN2401 and lemborexant. This data will be among nine abstracts communicated in one oral and eight poster presentations at the virtual Alzheimer's Association International Conference (AAIC), July 27-31, 2020.
"Eisai has a compelling track record of trailblazing in the field of Alzheimer's disease and dementia. The breadth of information Eisai will present demonstrates our continued dedication to bring patients therapies for Alzheimer's disease and its symptoms as soon as possible," said Harald Hampel, MD, Vice President, Chief Medical Officer, Neurology Business Group, Eisai Inc. "We look forward to sharing data and discussing the scientific rationale that the amyloid pathway plays a key role in the pathophysiology of Alzheimer's disease as well as the latest developments in biomarkers."
Eisai and Biogen Joint Investigational Assets
Eisai Presentations for BAN2401:
-- Study design for the Phase 3 AHEAD 3-45 trial of BAN2401 in patients
with early AD will be communicated as an oral presentation on July 29.
After a common screening period in AHEAD 3-45, participants will be
enrolled into one of two randomized, double-blind, placebo controlled
trials based on the level of amyloid in the brain: the A45 trial and the
A3 trial. AHEAD 3-45 is conducted as a public-private partnership
between the Alzheimer's Clinical Trial Consortium, funded by the
National Institute on Aging, part of the National Institutes of Health,
and Eisai.
-- Preliminary analysis of Amyloid Related Imaging Abnormalities -
Edema/Effusion (ARIA-E) rates. These results will be presented on July
29.
-- Preliminary assessment of BAN2401-mediated amyloid reduction for the 10
mg/kg bi-weekly dose of BAN2401 from the 18-month Phase 2b study
BAN2401-G000-201 open-label extension study. These results will be
presented on July 29.
Biogen Presentation for Aducanumab:
-- Biogen will share an encore platform presentation of the previously
reported topline results from the aducanumab Phase 3 EMERGE and ENGAGE
studies. No new data from the studies are included in the encore
presentation, which will be pre-recorded and followed by an online
question and answer (Q&A) session.
Additional Eisai AAIC Conference Highlights
A satellite symposium and additional studies will further explore key topics affecting AD patients.
-- An Eisai-sponsored virtual satellite symposium titled, "The Development
of the A/T/N/x Classification System for Different Contexts of Use
across the Alzheimer's Disease Continuum: State-of-the-Art and Future
Perspectives for Clinical Practice and Therapy Development," will be
available on-demand throughout the duration of the virtual program and
up to a month following the conference conclusion. The A/T/N system is
an unbiased descriptive classification scheme for AD biomarkers using
core AD pathophysiological mechanisms (amyloid- (A), tau (T) and
neurodegeneration (N)). The A/T/N/x system has the potential to guide AD
therapy development and clinical practice for a precision
medicine-oriented approach. The symposium will provide a
state-of-the-art A/T/N/x classification system across the AD continuum,
including main challenges in the validation and qualification process
for different contexts of use. Featured speakers will include:
-- Jeffrey Cummings, MD, ScD, Director, Chambers-Grundy Center for
Transformative Neuroscience, Department of Brain Health, UNLV,
Founding Director, Cleveland Clinic Lou Ruvo Center for Brain
Health, Cleveland Clinic
-- Clifford R. Jack, Jr., MD
-- Kaj Blennow, MD, PhD, Professor and Academic Chair in Clinical
Neurochemistry, Head of the Clinical Neurochemistry Lab, Sahlgrenska
University Hospital, University of Gothenberg
-- Additional studies covering the patient, caregiver and economic burden
of AD and its effect on daily living and quality of life will be
presented in a series of poster presentations.
-- Long-term safety and efficacy data from a Phase 2 extension study of
lemborexant in patients with irregular sleep-wake rhythm disorder
(ISWRD) and AD dementia will also be presented as a poster presentation.
Lemborexant was approved in December 2020 by the U.S. Food and Drug
Administration for the treatment of adult patients with insomnia,
characterized by difficulties with sleep onset and/or sleep
maintenance.(1) Lemborexant is contraindicated in patients with
narcolepsy.
"In addition to a robust pipeline of potential disease-modifying compounds targeting Alzheimer's pathological hallmarks of amyloid, tau and neurodegeneration, Eisai is researching other novel therapies aiming to treat both the disease and the clinical symptoms of Alzheimer's disease, such as cognition and sleep disorders," said Ivan Cheung, Chairman, Eisai Inc and Global President, Neurology Business Group, Eisai Co., Ltd. "With our partner Biogen's filing of the aducanumab Biologics License Application with the U.S. FDA, the initiation of the BAN2401 Phase 3 AHEAD 3-45 clinical study and the data presented at this year's AAIC, it is an incredibly exciting time for Eisai's growing Alzheimer's disease franchise."
The full list of Eisai and one Biogen (aducanumab) virtual presentations is included below. All presentations will be available on demand via the AAIC website approximately one month post-conference to registered participants. There is no charge to register for this year's event.
AAIC 2020 Presentations
Virtual Event
Title
---
Company- The Development of the A/T/N/x
Sponsored Classification System for
Satellite Different Contexts of Use Across
Symposium the Alzheimer's Disease Continuum:
State-of-the-Art and Future
Perspectives for Clinical Practice
and Therapy Development
---
Pipeline Title and Scheduled Presentation
Asset, Time (CDT)
Session
Number
---
BAN2401 AHEAD 3-45 Study Design: A Global
Study to Evaluate Efficacy and
Safety of Treatment with BAN2401
for 216 Weeks in Preclinical
Alzheimer's Disease with
Intermediate Amyloid (A3 Trial)
and Elevated Amyloid (A45 Trial)
Oral #: 44511 July 29 (Wednesday), 12:00AM -
11:59PM; chat room 11:00AM -
11:25AM
Session #:
ODO3-03
Presentation:
ODO3-03-05
Chat Room #:
48069
Session:
SCR3-13
Presentation:
SCR3-13-05
---
BAN2401 A Preliminary Account of ARIA-E in
the Ongoing Open Label Extension
Phase of BAN2401-G000-201 in
Subjects with Early Alzheimer's
Disease
Poster #: July 29 (Wednesday), 12:00AM -
46059 11:59PM
Session: P3
---
BAN2401 A Preliminary Assessment of
Longitudinal Amyloid Status in the
Ongoing Open-Label Extension
Phase in Subjects with Early
Alzheimer's Disease
Poster #: July 29 (Wednesday), 12:00AM -
46209 11:59PM
Session: P3
---
Lemborexant Long-Term Safety and Efficacy of
Lemborexant in Subjects with
Irregular Sleep-Wake Rhythm
Disorder and Alzheimer's Disease
Dementia
Poster #: July 29 (Wednesday), 12:00AM -
39039 11:59PM
Session: P3
---
General Evaluation of Patient Burden Using
Online Social Media in Cognitive
Impairment
Poster #: July 30 (Thursday), 12:00AM -
39448 11:59PM
Session: P4
---
General Healthcare Expenditures
Attributable to Alzheimer's
Disease in Japan: LIFE Study
Poster #: July 30 (Thursday), 12:00AM -
40698 11:59PM
Session: P4
---
General Impact on the Disease Severity on
Quality of Life, Activity of Daily
Living and Medical Costs for
People Living with Dementia in
Japanese Nursing Homes
Poster #: July 30 (Thursday), 12:00AM -
38365 11:59PM
Session: P4
---
Elenbecestat Amyloid Burden Assessed by Three
Amyloid PET Tracers in the
Elenbecestat MissionAD Phase 3
Program
Poster #: July 28 (Tuesday), 12:00AM -
43305 11:59PM
Session: P2
---
Elenbecestat Initial Exploration of a Brain Age
Score Based on Validated
Computerized Cognitive Assessments
in Japanese Individuals
Poster #: July 29 (Wednesday), 12:00AM -
45446 11:59PM
Session: P3
---
Biogen AAIC 2020 Presentations
Pipeline Title and Scheduled Presentation
Asset, Time (CDT)
Session
Number
---
Aducanumab EMERGE and ENGAGE Topline Results:
Phase 3 Studies of Aducanumab in
Early Alzheimer's Disease
Scheduled July 29 (Wednesday), 7:00AM -
Broadcast 8:00AM
of Oral
#:
S03-02-03
Virtual
Room:
Amsterdam
---
This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.
[Notes to editors]
1. About Aducanumab
Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of AD. Based on clinical data, aducanumab has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline and provide benefits on patients' ability to perform activities of daily living, including conducting personal finances, performing household chores, such as cleaning, shopping and doing laundry, and independently traveling out of the home. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer's.
2. About BAN2401
BAN2401 is an investigational humanized monoclonal antibody for Alzheimer's disease that is the result of a strategic research alliance between Eisai and BioArctic. BAN2401 selectively binds to neutralize and eliminate soluble, toxic A aggregates (protofibril) that are thought to contribute to the neurodegenerative process in AD. As such, BAN2401 may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for BAN2401 and the parties amended that agreement in October 2017.
Currently, BAN2401 is being studied in a pivotal Phase 3 clinical study in symptomatic early AD (Clarity AD), following the outcome of the Phase II clinical study (Study 201). In July of 2020, the Phase III clinical study ?AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, was initiated. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium, funded by the National Institute on Aging, part of the National Institutes of Health, and Eisai.
3. About the Joint Development between Eisai and Biogen for Alzheimer's Disease
Eisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Biogen serves as the lead in the co-development of aducanumab and Eisai serves as the lead in the co-development of BAN2401, anti-amyloid beta (A ) protofibril antibodies, and the companies plan to pursue marketing authorizations for aducanumab and BAN2401 worldwide. If approved, the companies will also co-promote aducanumab and BAN2401 in major markets, such as the United States, the European Union and Japan. Both companies will equally split overall costs, including research and development expenses. Eisai will book all sales for BAN2401 following marketing approval and launch, and profits will be equally shared between the companies.
4. About the Collaboration between Eisai and BioArctic for Alzheimer's Disease
Since 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the BAN2401 antibody was signed in December 2007, and the development and commercialization agreement on the antibody BAN2401 back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for BAN2401 in AD.
5. About Lemborexant
Lemborexant is a small-molecule compound, discovered and developed by Eisai in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). In individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness.(2) In individuals with insomnia, it is possible that orexin signaling regulating wakefulness is not functioning normally.
INDICATION
DAYVIGO (lemborexant) is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.(1)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
-- DAYVIGO is contraindicated in patients with narcolepsy.
WARNINGS AND PRECAUTIONS
-- Central Nervous System (CNS) Depressant Effects and Daytime Impairment:
DAYVIGO can impair daytime wakefulness. CNS depressant effects may
persist in some patients up to several days after discontinuing DAYVIGO.
Prescribers should advise patients about the potential for next-day
somnolence. Driving ability was impaired in some subjects taking DAYVIGO
10 mg. Risk of daytime impairment is increased if DAYVIGO is taken with
less than a full night of sleep remaining or at a higher than
recommended dose. If taken in these circumstances, patients should not
drive or engage in activities requiring mental alertness. Use with other
classes of CNS depressants (e.g., benzodiazepines, opioids, tricyclic
antidepressants, alcohol) increases the risk of CNS depression, which
can cause daytime impairment. Dosage adjustments of DAYVIGO and
concomitant CNS depressants may be necessary when administered together.
Use of DAYVIGO with other insomnia drugs is not recommended. Patients
should be advised not to consume alcohol in combination with DAYVIGO.
Because DAYVIGO can cause drowsiness, patients, particularly the
elderly, are at a higher risk of falls.
-- Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and
Cataplexy-Like Symptoms:Sleep paralysis, an inability to move or speak
for up to several minutes during sleep-wake transitions,
hypnagogic/hypnopompic hallucinations, including vivid and disturbing
perceptions can occur with DAYVIGO. Prescribers should explain these
events to patients. Symptoms similar to mild cataplexy can occur with
DAYVIGO and can include periods of leg weakness lasting from seconds to
a few minutes, can occur either at night or during the day, and may not
be associated with identified triggering event (e.g., laughter or
surprise).
-- Complex Sleep Behaviors:Complex sleep behaviors, including
sleep-walking, sleep-driving, and engaging in other activities while not
fully awake (e.g., preparing and eating food, making phone calls, having
sex), have been reported to occur with the use of hypnotics such as
DAYVIGO. Events can occur in hypnotic-naïve and hypnotic-experienced
persons. Patients usually do not remember these events. Complex sleep
behaviors may occur following the first or any subsequent use of
DAYVIGO, with or without the concomitant use of alcohol and other CNS
depressants. Discontinue DAYVIGO immediately if a patient experiences a
complex sleep behavior.
-- Patients with Compromised Respiratory Function:The effect of DAYVIGO on
respiratory function should be considered for patients with compromised
respiratory function. DAYVIGO has not been studied in patients with
moderate to severe obstructive sleep apnea (OSA) or chronic obstructive
pulmonary disease (COPD).
-- Worsening of Depression/Suicidal Ideation:Incidence of suicidal ideation
or suicidal behavior, as assessed by questionnaire, was higher in
patients receiving DAYVIGO than placebo (0.3% for DAYVIGO 10 mg, 0.4%
for DAYVIGO 5 mg, and 0.2% for placebo). In primarily depressed
patients treated with hypnotics, worsening of depression and suicidal
thoughts and actions (including completed suicides) have been reported.
Suicidal tendencies may be present in such patients and protective
measures may be required. Intentional overdose is more common in this
group of patients; therefore, the lowest number of tablets that is
feasible should be prescribed at any one time. The emergence of any new
behavioral sign or symptom of concern requires careful and immediate
evaluation.
-- Need to Evaluate for Comorbid Diagnoses:Treatment of insomnia should be
initiated only after careful evaluation of the patient. Reevaluate for
comorbid conditions if insomnia persists or worsens after 7 to 10 days
of treatment. Worsening of insomnia or the emergence of new cognitive or
behavioral abnormalities may be the result of an unrecognized underlying
psychiatric or medical disorder and can emerge during the course of
treatment with sleep-promoting drugs such as DAYVIGO.
ADVERSE REACTIONS
-- The most common adverse reaction (reported in 5% of patients treated
with DAYVIGO and at least twice the rate of placebo) with DAYVIGO was
somnolence (10% for DAYVIGO 10 mg, 7% for DAYVIGO 5 mg, 1% for placebo).
DRUG INTERACTIONS
-- CYP3A Inhibitors: The maximum recommended dose of DAYVIGO is 5 mg no
more than once per night when co-administered with weak CYP3A
inhibitors. Avoid concomitant use of DAYVIGO with strong or moderate
CYP3A inhibitors.
-- CYP3A Inducers: Avoid concomitant use of DAYVIGO with moderate or strong
CYP3A inducers.
USE IN SPECIFIC POPULATIONS
-- Pregnancy and Lactation: There is a pregnancy exposure registry that
monitors pregnancy outcomes in women who are exposed to DAYVIGO during
pregnancy. Healthcare providers are encouraged to register patients in
the DAYVIGO pregnancy registry by calling 1-888-274-2378. There are no
available data on DAYVIGO use in pregnant women to evaluate for a
drug-associated risk of major birth defects, miscarriage, or adverse
maternal or fetal outcomes. There are no data on the presence of
lemborexant in human milk, the effects on the breastfed infant, or the
effects on milk production. Infants exposed to DAYVIGO through
breastmilk should be monitored for excess sedation.
-- Geriatric Use: Exercise caution when using doses higher than 5 mg in
patients >=65 years old.
-- Renal Impairment: Patients with severe renal impairment may experience
an increased risk of somnolence.
-- Hepatic Impairment: The maximum recommended dose of DAYVIGO is 5 mg in
patients with moderate hepatic impairment. DAYVIGO is not recommended in
patients with severe hepatic impairment. Patients with mild hepatic
impairment may experience an increased risk of somnolence.
DRUG ABUSE AND DEPENDENCE
-- DAYVIGO is a Schedule IV-controlled substance.
-- Because individuals with a history of abuse or addiction to alcohol or
other drugs may be at increased risk for abuse and addiction to DAYVIGO,
follow such patients carefully.
For more information about DAYVIGO, see full Prescribing Information.
6. About Elenbecestat
Elenbecestat is Eisai's in-house discovered and developed BACE (beta-site amyloid precursor protein cleaving enzyme) inhibitor. Phase 3 clinical studies (MISSION AD1, AD2) for elenbecestat aimed at early AD were discontinued in September 2019.
7. About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.
References
(1) Eisai Inc. DAYVIGO Full Prescribing Information. 2020.
(2 )Scammell TE, Winrow CJ. Orexin receptors: pharmacology and therapeutic opportunities. Annu Rev Pharmacol Toxicol. 2011;51:243-266.
Contact:
Eisai Inc.
Libby Holman
201-753-1945
libby_holman@eisai.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/eisai-alzheimers-disease-pipeline-research-to-be-presented-at-virtual-aaic-2020-including-ban2401-and-lemborexant-data-and-a-biomarker-symposium-301099274.html
SOURCE Eisai Inc.
