Q3 2023 Results
Company overview
Financial review
Conclusions
Appendix
References
INNOVATION
Iptacopan demonstrated clinically meaningful and highly
statistically significant proteinuria reduction in Ph3 APPLAUSE-IgAN
Ph3 APPLAUSE-IgAN
Biopsy-confirmed patients with IgA nephropathy at risk of
progression with elevated proteinuria (UPCR1 ≥1g/g) despite
stable background therapy²
Randomization
Interim analysis
End of study
n= 250 at 9 months
n = ~430
☹
R
1:1
Iptacopan 200mg BID³
Placebo
Day 1
|
I
Month 9
Option to
roll-over in
open-label
extension
study
Month 24 (2025)
Positive top-line results at pre-specified
interim analysis
Superiority vs placebo in proteinuria reduction
on top of optimized supportive care
Clinically meaningful and highly statistically significant
proteinuria reduction
Safety profile consistent with previously reported data
Oral
Next steps
In discussions with FDA to submit for accelerated approval
Study continues to assess superiority in slowing disease
progression (eGFR slope) for full approval
IgAN - IgA nephropathy. eGFR - estimated glomerular filtration. 1. UPCR (urine protein-to-creatinine ratio) from 24-h urine collection. 2. Including at least maximally tolerated dose of ACEI/ARB for at least 90 days.
20 Investor Relations | Q3 2023 Results
3. BID twice daily.
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