ANNUAL REPORT 2021
LUNDBECK
ANNUAL REPORT 2021
= CONTENTS
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In December 2020, the filling of eptinezumab was accepted by
the European Medicines Agency (EMA) for marketing
authorization application (MAA) review. In addition,
eptinezumab currently is under regulatory review in Argentina,
Brazil, Chile, Columbia, Indonesia, Israel, Hong Kong,
Philippines, Saudi Arabia, South Africa, Taiwan, Thailand and
the UK.
In November 2021, we announced positive results from
the phase IIIb DELIVER study assessing the efficacy and safety
of VyeptiⓇ (eptinezumab) 100mg and 300mg IV infusion in
patients with chronic or episodic migraine who had experienced
two to four previous preventive treatment failures due to lack of
efficacy or intolerable side effects.
During the first half of 2021, Lundbeck initiated the SUNLIGHT
and SUNRISE phase III clinical trials. These trials will support
registration for migraine prevention in Asia, including China and
Japan, and are progressing as planned and are expected to
complete in 2022 and 2023.
In December 2020, Lundbeck initiated the ALLEVIATE phase III
clinical trial investigating the efficacy of eptinezumab in patients
with episodic cluster headache. The trial is progressing as
planned and is expected to complete in 2023. The primary
outcome in the trial is change from baseline in number of weekly
attacks, averaged over weeks 1-2.
Lu AG09222 (former ALD 1910)
Following supportive phase I target engagement data, a phase
Il proof-of-concept study in migraine prevention commenced in
November 2021. Lu AG09222 is a monoclonal antibody (mAb)
designed to bind pituitary adenylate cyclase-activating
polypeptide (PACAP), thereby effectively preventing PACAP
from activating its receptors. PACAP has emerged as an
important signaling molecule in the pathophysiology of migraine
and represents an attractive novel target for treating migraine.
Lu AG09222 may hold potential as a migraine prevention
treatment and could provide another mechanism-specific
therapeutic option for migraine patients and their physicians.
C
CIRCUITRY/NEURONAL BIOLOGY
Brexpiprazole-phase III in Alzheimer's agitation
In April 2021, Lundbeck and Otsuka announced the decision to
continue the recruitment of patients in a third phase III clinical
trial of brexpiprazole in the treatment of agitation in patients with
dementia of the Alzheimer's type (NCT03548584). The decision
to continue the trial is based on the results of an independent
interim analysis, which support progressing the trial to the
planned full enrollment of 330 patients. The study is designed to
assess the safety, tolerability and efficacy of brexpiprazole in
the treatment of patients with agitation in Alzheimer's dementia.
The trial consists of a continuous 12-week double-blind
treatment period with a 30-day follow-up. The trial population is
planned to include 330 male and female patients, aged 55-90
years, with a diagnosis of probable Alzheimer's disease.
The continuation of the study enables Lundbeck and Otsuka to
further explore the efficacy of brexpiprazole to address the high
medical need in patients suffering from agitation in Alzheimer's
type dementia. Completion of the trial is expected in the first half
of 2022.
The primary outcome in the study is change in the Cohen-
Mansfield Agitation Inventory (CMAI) Total score. The key
secondary outcome measure is change in the Clinical Global
Impression - Severity of Illness (CGI-S) score, as related to
symptoms of agitation.View entire presentation