Reimagining Medicine Q2 2023 Results
Company overview
Financial review
Conclusions
Innovation: Pipeline overview
Financial performance
Cardiovascular
Immunology
iptacopan - CFB inhibitor
Appendix
Innovation: Clinical trials
Neuroscience
Oncology
iptacopan - CFB inhibitor
References
Abbreviations
Other
NCT04578834 APPLAUSE-IgAN (CLNP023A2301)
Indication
Phase
IgA nephropathy
Phase 3
Indication
Phase
NCT05755386 APPARENT (CLNP023B12302)
Immune complex-mediated membranoproliferative glomerulonephritis
Phase 3
Patients
450
Patients
68
Primary
Outcome
Measures
Ratio to baseline in urine protein to creatinine ratio (sampled from 24h urine
collection) at 9 months
Primary
Outcome
Measures
Annualized total estimated Glomerular Filtration Rate (eGFR) slope estimated
over 24 months
Arms
Intervention
Arm 1 LNP023 200mg BID
Arm 2 - Placebo BID
Target
Primary IgA Nephropathy patients
Patients
Readout
Milestone(s)
2023 (primary endpoint for US initial submission, 9 months UPCR)
2025 (24 months)
Publication
Perkovic et al. 2021, Nephrology Dialysis Transplantation, Vol. 36, Suppl. 1:
Study Design
Arms
Intervention
Target
Patients
Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine
collection) at 6 months. [ Time Frame: 6 months (double-blind) ]
To demonstrate the superiority of iptacopan compared to placebo in reducing
proteinuria at 6 months.
Log-transformed ratio to baseline in UPCR at the 12-month visit (both study
treatment arms) [ Time Frame: 12 months ]
To evaluate the effect of iptacopan on proteinuria at 12 months.
Log-transformed ratio to 6-month visit in UPCR at the 12-month visit in the
placebo arm. [ Time Frame: 12 months ]
To evaluate the effect of iptacopan on proteinuria at 12 months.
Arm 1 experimental: Drug: iptacopan 200 mg b.i.d. (Adults 200mg b.i.d;
Adolescents 2x 100mg b.i.d)
Arm 2 placebo to iptacopan 200mg b.i.d.
(both on top of SoC)
Patients (adults and adolescents aged 12-17 years) with idiopathic IC-MPGN
44 Investor Relations | Q2 2023 Results
Readout
Milestone(s)
Publication
2026
TBD
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