Q4 2022 Results slide image

Q4 2022 Results

Company overview Innovation: Pipeline overview Cardiovascular Financial review Immunology remibrutinib - BTK inhibitor 2023 priorities Innovation: Clinical trials Neuroscience NCT05030311 REMIX-1 (CLOU064A2301) Chronic spontaneous urticaria Indication Phase Phase 3 Patients 450 Primary Outcome Measures Arms Intervention Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint) Arm 1: LOU064 (blinded) LOU064 (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2) Arm 2: LOU064 placebo (blinded) LOU064 placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2) Adult Chronic Spontaneous Urticaria (CSU) patients inadequately controlled by H1-antihistamines Target Patients Readout Milestone(s) 2024 Publication TBD 75 Investor Relations | Q4 2022 Results Oncology remibrutinib - BTK inhibitor Appendix Abbreviations Other NCT05032157 REMIX-2 (CLOU064A2302) Chronic spontaneous urticaria Phase 3 Indication Phase Patients 450 Primary Outcome Measures Arms Intervention Target Patients 1. Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint) 2. Absolute change in ISS7 an absolute change in HSS7 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints) Arm 1: LOU064 (blinded) LOU064A (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open- label) taken orally open label for 28 weeks Arm 2: LOU064 placebo (blinded) LOU064A placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks Eligible participants randomized to the treatment arms in a 2:1 ratio (arm 1: arm 2) Adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo Readout Milestone(s) Publication 2024 TBD 1 NOVARTIS | Reimagining Medicine
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