Q1 2023 Results slide image

Q1 2023 Results

Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology remibrutinib - BTK inhibitor Appendix Innovation: Clinical trials Neuroscience Oncology remibrutinib - BTK inhibitor Indication NCT05030311 REMIX-1 (CLOU064A2301) Chronic spontaneous urticaria Indication NCT05032157 REMIX-2 (CLOU064A2302) Chronic spontaneous urticaria Phase Phase 3 Phase Phase 3 Patients 450 Patients 450 Primary Outcome Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint) Measures Primary Outcome Measures Arms Intervention Target Patients 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 Readout Milestone(s) 2024 (Final) Publication TBD 62 Investor Relations | Q1 2023 Results Arms Intervention References Abbreviations Other 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 2024 (Final) Target Patients Readout Milestone(s) Publication TBD 1 NOVARTIS | Reimagining Medicine
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