Half-Year 2022 Financial and Clinical Trials Update slide image

Half-Year 2022 Financial and Clinical Trials Update

Crovalimab (RG6107; SKY59) A humanized monoclonal antibody against complement C5 Indication Paroxysmal nocturnal hemoglobinuria (PNH) Roche Paroxysmal nocturnal hemoglobinuria (PNH) patients switching from a C5 inhibitor Phase/study # of patients Design Primary endpoint Status CT Identifier In collaboration with Chugai Phase I/II COMPOSER N=59 ☐ Healthy volunteers and treatment naïve and pretreated patients with PNH: Part 1: Single ascending dose study in healthy subjects Part 2: Intra-patient single ascending dose study in PNH patients Part 3: Multiple-dose study in PNH patients ■ Part 4: Dose confirmation in PNH patients • Safety, PK, PD Part 1: FPI Q4 2016 Part 2/3: FPI Q2 2017 Part 4: FPI Q2 2019 • Nonclinical data published in Scientific Reports 2017 Apr; 7(1):1080 Data presented for Part 2 and 3 at ASH 2018 and 2019 NCT03157635 " ARM A: Crovalimab Phase III COMMODORE 1 N=250 " " ARM B: Eculizumab ▪ ARM C: Patients switching to crovalimab from ravulizumab, higher than labeled doses of eculizumab & C5 SNP patients (descriptive-arm) Non-inferiority of crovalimab compared to eculizumab - mean % change in LDH level (measure of haemolysis) from baseline to week 25 FPI Q3 2020 ASH-American Society of Hematology; PNH=Paroxysmal nocturnal hemoglobinuria; PK/PD=Pharmacokinetics/Pharmacodynamics; LDH-Lactate Dehydrogenase NCT04432584 139 Immunology
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