Lundbeck Q3 2019 Financial Results
Brexpiprazole PoC study in borderline personality disorder commenced
Borderline Personality Disorder (BPD)
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Pharmacotherapy focuses on key symptoms (aggression, irritability, depressed mood, behavioural dyscontrol and
affective dysregulation, anxiety, psychoticism and hostility)
Substantial unmet medical need - no drugs approved for BPD
1.5-2 million potential patients in the U.S.
Study
objective¹)
To evaluate the efficacy and safety of 12-week brexpiprazole for the treatment of subjects diagnosed
with BPD (n = 240) to provide a pharmacological treatment for BPD
PoC study (phase II):
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Brexpiprazole (flexible dose 2-3mg) and placebo
Primary endpoint: Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) total score (Week 12)
Secondary endpoints: Clinical Global Impression - Severity of Illness (CGI-S); Patient's Global Impression of Severity (PGI-
S); Patient's Global Impression of Change (PGI-C) Scale; Clinical Global Impression - Improvement (CGI-I) Scale
Headline results due in 2021 - Fast Track designation granted October 2019
1) Clinicaltrials.gov ID: NCT04100096
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