Q1 2022 Results
Company overview
Financial performance
CRM
Immunology
Financial review
Neuroscience
2022 priorities
Innovation: Pipeline overview
Ophthalmology
iptacopan - CFB inhibitor
Study
Indication
Phase
NCT04154787 (CLNP023D12201)
Idiopathic membranous nephropathy (iMN)
Phase 2
Patients
72
Primary Outcome
Measures
Arms Intervention
Appendix
References
Innovation: Clinical trials
Abbreviations
Respiratory & Allergy
Oncology: Solid Tumors
Hematology
Biosimilars
Global Health
NCT04578834 APPLAUSE-IgAN (CLNP023A2301)
IgA nephropathy
Phase 3
450
Change from baseline of UPCR derived from 24hr urine collections at Baseline and
Week 24
Ratio to baseline in urine protein to creatinine ratio (sampled from 24h urine
collection) at 9 months
Annualized total estimated Glomerular Filtration Rate (eGFR) slope estimated over
24 months
Arm 1 - LNP023 200mg BID
Arm 2 - Placebo BID
Target Patients
Read-out Milestone(s)
2023
Publication
TBD
53 Investor Relations | Q1 2022 Results
LNP023 low dose
LNP023 high dose
Rituximab
Patients with biopsy proven iMN who are at high risk of disease progression defined
on the basis of antibody anti-PLA2R titre and proteinuria
Primary IgA Nephropathy patients
2023 (primary endpoint for US initial submission, 9 months UPCR)2025 (24 months)
Perkovic et al. 2021, Nephrology Dialysis Transplantation, Vol. 36, Suppl. 1: Study
Design
Wong et al. 2021, Nephrology Dialysis Transplantation, Vol. 36, Suppl. 1:
IPTACOPAN (LNP023): A NOVEL ORAL COMPLEMENT
ALTERNATIVE PATHWAY FACTOR B INHIBITOR SAFELY AND EFFECTIVELY
STABILISES EGFR IN C3 GLOMERULOPATHY
U NOVARTIS | Reimagining MedicineView entire presentation