Reimagining Medicine
Company overview
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Appendix
Upcoming 9 months analysis from IgAN Ph3 study (APPLAUSE)
could potentially support US Subpart H filing
APPLAUSE-IgAN: Biopsy-confirmed patients with IgAN at risk of progression with elevated proteinuria
(UPCR1 ≥1g/g) despite being on stable background therapy²
Iptacopan 200mg BID³
RE
1:1
Placebo
9 months analysis
↓
I
I
24 months
24 months
End of study
INNOVATION
Option to roll over
in open-label
extension study
H2 2023
Enrollment completed
Assess superiority in
reduction of proteinuria¹ at 9 months
Potentially supporting US Subpart H
regulatory submission for accelerated approval
2025
Enrollment ongoing
Assess superiority in
slowing progression of IgAN
Submission enabling readout
for full approval
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.
3. BID twice daily.
19 Investor Relations | Q4 2022 Results
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