9M 2023 Financial Overview
9M 2023: APPENDIX
Brexpiprazole, in combination with sertraline, is being
evaluated in two phase III PTSD trials
High unmet need in Post-
Traumatic Stress Disorder
(PTSD)
• ~8.6m U.S. adults affected, but ~80%
estimated to be undiagnosed 1.2)
•
•
Growing economic and social burden of
care
Inadequate response with approved
SSRIS polypharmacy the norm
Exploratory PoC study in PTSD³)
suggested effects of brexpiprazole
in combination with sertraline
.
The combination of brexpiprazole and
sertraline showed improvement versus
placebo (p<0.01) on the primary
endpoint (CAPS-5 total score)4)
• Brexpiprazole or sertraline alone did not
demonstrate an effect
Phase III program
(Data read-out expected in
H2 2023)
•
Study #1: Flexible-dose study5)
12-week treatment period
Placebo
Sertraline up to 150 mg/day
Brexpiprazole 3mg + sertraline up to 150mg/day
20
20
•
•
The overall safety and tolerability of
brexpiprazole were good
Study #2: Fixed-dose study6)
1) Nature Reviews Disease Primers; Vol 1, 2015. 2) National Institute of Mental Health. 3) NCT03033069. 4) Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
5) Clinicaltrials.gov ID: NCT04124614. 6) NCT04174170
12-week treatment period
Placebo
Sertraline up to 150 mg/day
Brexpiprazole 2mg + sertraline up to 150mg/day
Brexpiprazole 3mg + sertraline up to 150mg/day
LundbeckView entire presentation