ANNUAL REPORT 2021
LUNDBECK
ANNUAL REPORT 2021
= CONTENTS
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DECENTRALIZED CLINICAL TRIALS
In 2021, we maintained our COVID crisis-
management plans across our portfolio of ongoing
clinical trials. The goal was to provide continuity of
clinical trial supplies to patients and ensure patient
visits and study assessments were conducted as
planned.
Patient visits continued at clinics where possible
and remote visits were implemented in cases where
travel restrictions were in place.
In 2021, we also embarked on our first pre-planned
Hybrid Decentralized trial, where patients have the
choice of either visiting their trial site or selecting to
have remote visits in their own home setting.
The first study is the Lu AG09222 phase II
proof-of-concept study in migraine
prevention and we had first patient visits in
November 2021.
Brexpiprazole-phase III in Post-Traumatic Stress Disorder
(PTSD)
PTSD is a psychiatric disorder that can develop as a response
to traumatic events, such as interpersonal violence, combat, life-
threatening accidents or natural disasters.
Core features of PTSD include a variety of symptoms, such as
re-experiencing phenomena (i.e. flashbacks and nightmares),
avoidance behavior, numbing (i.e. amnesia, anhedonia,
withdrawal, negativism) and increased arousal (i.e. insomnia,
irritability, poor concentration, hypervigilance). Psychiatric co-
morbidities are common, and PTSD sufferers can also present
with substance abuse, mood and other anxiety disorders,
impulsive and dangerous behavior and self-harm.
Lundbeck and Otsuka reported positive phase II data for the
combination treatment of brexpiprazole and sertraline for the
treatment of PTSD in November 2018. On basis of these data,
Lundbeck and Otsuka initiated two pivotal phase III trials
(NCT04124614; n=577 and NCT04174170; n=733),
investigating the use of brexpiprazole in combination with
sertraline in the treatment of PTSD subsequent to an End of
Phase II meeting with the FDA in May 2019. The execution of
those two ongoing studies is challenged by the COVID-19
pandemic, primarily impacting enrollment activities and
Lundbeck and Otsuka are exploring options on how best to
address these COVID-19 challenges.
Brexpiprazole - SNDA for treatment of schizophrenia in
adolescents
In December 2021, the FDA approved Lundbeck's and Otsuka's
SNDA for the treatment of schizophrenia in adolescents with
RexultiⓇ (brexpiprazole). More specifically, RexultiⓇ/Rxulti® is
now approved for the treatment of schizophrenia in pediatric
patients 13 to 17 years of age.
Currently, RexultiⓇ is approved in the U.S. for treatment of
schizophrenia in adults and adjunctive treatment of major
depressive disorder in adults. The submission was completed
one year earlier than planned, with the hope of benefitting
adolescent patients with schizophrenia who need more
treatment options. The acceleration of the program was made
possible by doing an extrapolation analysis using data from prior
studies in adult patients, pharmacokinetic results from adult and
pediatric trials, and 6-month data from the ongoing open-label,
long-term trial in adolescent schizophrenia patients (Trial 331-
10-236).
Aripiprazole -2-Month Injectable (LAI) formulation
Dosing every second month can add important benefits in terms
of convenience for patients and may increase treatment
adherence as well as minimizing the risk of missing doses. It
may also reduce the potential need for medication monitoring by
healthcare professionals, family and caregivers.
In July 2019, Lundbeck and Otsuka initiated a pivotal phase 1b
study (NCT04030143) to determine the safety, tolerability and
pharmacokinetics of multiple-dose administrations of
aripiprazole to adult participants with schizophrenia or bipolar I
disorder. The study was an open-label, multiple-dose,
randomized, parallel-arm, multicenter study. In addition to the
assessment of safety and tolerability, the objective was to
establish the similarity of aripiprazole concentrations on the last
day of the dosing interval and the exposure in the last dosing
interval following the final administration of aripiprazole into the
gluteal muscle site. The study showed that the new 2-Month
formulation was safe and tolerable, and provided effective
plasma concentrations of aripiprazole for two months.
No further clinical studies are expected to be required and as a
next step the regulatory agencies in the U.S. and the EU will be
approached. Scale-up of manufacturing capacity is progressing
at Otsuka with regulatory submission gated on completing build
and validation of new manufacturing capacity at Otsuka.
Lundbeck and Otsuka are planning to submit the aripiprazole 2-
Month injectable formulation to the EMA for MAA review by mid-
2022. In addition, Lundbeck and Otsuka will submit the New
Drug Application (NDA) for review by the FDA in mid-2022.View entire presentation