9M 2023 Financial Overview slide image

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 Lundbeck
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