ANNUAL REPORT 2021
LUNDBECK
ANNUAL REPORT 2021
= CONTENTS
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DIGITAL HEALTH TOOLS IN
CLINICAL TRIALS
In 2021, three different digital health tools were
implemented in four phase lb studies of Lu
AG06466 and Lu AG06479. The digital health tools
include a sleep and seizure monitoring
actigraphy wristband, a sleep monitoring EEG
headband, and digital insoles that are placed in the
patient's shoes for gait assessment.
The inclusion of these tools represents Lundbeck's
aim to explore the benefits of digitally obtained
endpoints. The tools also allow Lundbeck to
combine sensor data and novel algorithms,
providing objective insights into previously
undiscovered domains.
By targeting pathological alpha-synuclein with an antibody that
will inhibit aggregation and potentially clear pathological alpha-
synuclein from the brain, the project aims to demonstrate delay
of disease progression with a therapeutic effect on disease
burden and function. A phase II proof-of-concept study program
on Lu AF82422 commenced in November 2021 to investigate
the safety and efficacy of Lu AF82422 in MSA. Orphan drug
designation for MSA was granted by EMA in April 2021.
Lu AF87908-phase I
Lu AF87908 is a monoclonal antibody (mAb) targeting the
pathological form of the hyper-phosphorylated tau protein, which
is believed to play a pivotal role in the development and
progression of Alzheimer's disease and other tau-driven
neurodegenerative disorders (primary tauopathies). Lu AF87908
binds to a specific tau epitope (pS396-tau) which is a
dominating phosphorylation site in pathological tau.
A Phase I program on Lu AF87908 commenced in September
2019 to investigate the safety and tolerability as well as
pharmacokinetics of a single dose of Lu AF87908, in healthy
subjects and patients with Alzheimer's disease (NCT04149860).
OTHER PROJECTS
In July 2021, Lundbeck announced the licensing of global rights
for idalopirdine to Denovo Biopharma, including all rights to
develop, manufacture and commercialize idalopirdine for all
indications. Denovo Biopharma aims to explore idalopirdine
using its biomarker platform, applying a precision medicine
approach to develop innovative therapies. Lundbeck holds the
right to re-acquire idalopirdine, while the rights in China would
be shared with Denovo Biopharma. Idalopirdine was previously
developed by Lundbeck, in collaboration with Otsuka, for
cognitive symptoms in Alzheimer's disease. The idalopirdine-
project did not reach a successful outcome in a phase III trial in
2017.View entire presentation