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
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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
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ARM A: Crovalimab
Phase III
COMMODORE 1
N=250
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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
ImmunologyView entire presentation