Q4 2021 Results
Participants
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
Financial performance
Innovation: Pipeline overview
Innovation: Clinical trials
CRM
IHD
Neuroscience
Ophthalmology
Respiratory & Allergy
Oncology: Solid Tumors
Hematology
Biosimilars
Global Health
Abbreviations
iptacopan - CFB inhibitor
Study
Indication
Phase
NCT04154787 (CLNP023D12201)
Idiopathic membranous nephropathy (iMN)
Phase 2
NCT04578834 APPLAUSE-IgAN (CLNP023A2301)
IgA nephropathy
Phase 3
Patients
72
450
Primary Outcome
Measures
Change from baseline of UPCR derived from 24hr urine collections at Baseline and
Week 24
Arms Intervention
Target Patients
Read-out Milestone(s)
2023
Publication
TBD
75 Investor Relations | Q4 2021 Results
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
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