Q2 2021 Results - Reimagining Medicine
Participants
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
References
3
INNOVATION
Iptacopan shows clinically meaningful reduction in proteinuria
and stabilization of renal function in patients with IgAN and C3G
IgAN
Primary endpoint data
presented at ERA-EDTA 2021
C3G
IA data on primary endpoint
presented at ASN 2020
EU PRIME designation
UPCR (24-hour urine collection) (g/mol)
ratio to placebo (of ratio to baseline)
1.2-
MCP-mod estimates
X MMRM estimates
Estimated dose-response curve
Pointwise 80% CI
1.0-
0.8-
0.6-
1-sided P=0.038
for dose-response effect
0.4-
0 10
50
100
Iptacopan dose (mg)
■ 23% reduction in proteinuria at 3 months (200mg BID)
"
Encouraging trend to early stabilization of renal function (eGFR)
■ Well tolerated; no serious infections
■ Ph3 APPLAUSE-IgAN: Ongoing to support iptacopan filings worldwide
BID twice daily
200
UPCR 24 h ratio to baseline (80% CI)
1.0
0.9
0.8
0.7
0.6
0.5
0.4
Patient dose escalation: 10mg-100mg b.i.d. during weeks 1-3,
followed by 200mg b.i.d. from weeks 4-12
Number of patients with non-missing measurements
12
Baseline
Day 28
Time, days
0.51 (0.42, 0.63)
One sided p = 0.0005
Day 84
■ 49% reduction in proteinuria at 3 months
■ Stabilization of renal function (eGFR) at 3 months
■ Well tolerated with no unexpected or new safety findings
■Final Ph2 readout imminent
■ Ph3 APPEAR-C3G: Enrolling, will support filings worldwide
MMRM - mixed model repeated measurements UPCR - Urine protein to creatinine ratio
CI-confidence interval eGFR - estimated glomerular filtration rate MCP-mod - Multiple Comparison Procedure-Modelling
13 Investor Relations | Q2 2021 Results
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