Press Release: Novartis atrasentan Phase III data -2-

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References

1. Heerspink HJL, Jardine M, Kohan D, et al. ALIGN Phase 3 Primary Endpoint

Analysis: Atrasentan Shows Significant Reduction in Proteinuria in

Patients with IgA Nephropathy. Presented at European Renal Association

(ERA) Congress; May 25, 2024; Stockholm, Sweden.

2. Tycová I, Hrubá P, Maixnerová D, et al. Molecular

Profiling in IgA Nephropathy and Focal and Segmental

Glomerulosclerosis. Physiol Res. 2018;67(1):93-105.

doi:10.33549/physiolres.933670

3. Lehrke I, Waldherr R, Ritz E, Wagner J. Renal Endothelin-1 and Endothelin

Receptor Type B Expression in Glomerular Diseases with Proteinuria. J Am

Soc Nephrol. 2001;12(11):2321-2329. doi:10.1681/ASN.V12112321

4. Zanatta CM, Veronese FV, Loreto Mda S, et al. Endothelin-1 and Endothelin

A Receptor Immunoreactivity is Increased in Patients with Diabetic

Nephropathy. Ren Fail. 2012;34(3):308-315.

doi:10.3109/0886022X.2011.647301

5. Kohan DE, Barton M. Endothelin and Endothelin Antagonists in Chronic

Kidney Disease. Kidney Int. 2014;86(5):896-904. doi:10.1038/ki.2014.143

6. Kidney Disease: Improving Global Outcomes (KDIGO) 2021 Clinical Practice

Guideline for the Management of Glomerular Diseases. Kidney Int.

2021;100(4):S1-S276. doi:10.1016/j.kint.2021.05.021

7. Boyd JK, Cheung CK, Molyneux K, Feehally J, Barratt J. An Update on the

Pathogenesis and Treatment of IgA Nephropathy. Kidney Int.

2012;81(9):833-843. doi:10.1038/ki.2011.501

8. Reich HN, Troyanov SAA, Scholey JW, Cattran DC. Remission of Proteinuria

Improves Prognosis in IgA Nephropathy. J Am Soc Nephrol.

2007;18(12):3177-3183. doi:10.1681/ASN.2007050526

9. Kim SG, Inker LA, Packham DK, et al. WCN23-1126 Atrasentan for the

Treatment of IgA Nephropathy: Interim Results of the AFFINITY

Study. Kidney Int Rep. 2023;8(9):1902. doi:10.1016/j.ekir.2023.02.1088

10. Thompson A, Carroll K, Inker LA, et al. Proteinuria Reduction as a

Surrogate End Point in Trials of IgA Nephropathy. Clin J Am Soc Nephrol.

2019;14(3):469-481. doi:10.2215/CJN.08600718

11. ClinicalTrials.gov. NCT04573478. A Phase 3, Randomized, Double-Blind,

Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy

at Risk of Progressive Loss of Renal Function (ALIGN). Available from:

https://clinicaltrials.gov/study/NCT04573478. Accessed May 2024.

12. Lambers Heerspink H, Jardine M, Kohan DE, et al. WCN23-1085 A Phase 3,

Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in

Patients with IgA Nephropathy -- The ALIGN Study. Kidney Int Rep.

2023;8(3):S279-S280. doi:10.1016/j.ekir.2023.02.630.

13. Kavanagh D, Bomback A, Vivarelli M, et al. Efficacy and Safety of

Iptacopan in Patients with C3 Glomerulopathy: Results from the Phase 3

APPEAR-C3G Trial. Presented at European Renal Association (ERA) Congress;

May 25, 2024; Stockholm, Sweden.

14. Nester CM, Eisenberger U, Karras A, et al. Update to the Long-Term Safety

and Efficacy of Iptacopan in C3G: 33-Month Extension Study Data from

Patients Enrolled in a Phase 2 Study. Presented at European Renal

Association (ERA) Congress; May 25, 2024; Stockholm, Sweden.

15. Perkovic V, Kollins D, Papachristofi O, et al. Efficacy and Safety of

Iptacopan in Patients with Primary IgA Nephropathy: Interim Analysis

Results of the Phase 3 APPLAUSE-IgAN Study. Presented at European Renal

Association (ERA) Congress; May 25, 2024; Stockholm, Sweden.

16. Barratt J, Kooienga L, Agha I, et al. One Year of Zigakibart Treatment

Shows Clinically Meaningful Proteinuria Reduction and Good Tolerability

in a Phase 1/2 Study of IgA Nephropathy. Presented at European Renal

Association (ERA) Congress; May 25, 2024; Stockholm, Sweden.

17. ClinicalTrials.gov. NCT04573920. A Phase 2, Open-Label, Basket Study of

Atrasentan in Patients with Proteinuric Glomerular Diseases (AFFINITY).

Available from: https://clinicaltrials.gov/study/NCT04573920. Accessed

May 2024.

18. Sasser JM, Sullivan JC, Hobbs JL, et al. Endothelin A Receptor Blockade

Reduces Diabetic Renal Injury via an Anti-Inflammatory Mechanism. J Am

Soc Nephrol. 2007;18(1):143-154. doi:10.1681/ASN.2006030208

19. Olson E, McConnell M, Ragan S, et al. MO264: Selective Endothelin A

Receptor Antagonist Atrasentan Attenuates Mesangial Cell Injury,

Proteinuria and Intra-Renal Proliferative, Inflammatory and Fibrotic

Transcriptional Networks in a Rat Model of Mesangioproliferative

Glomerulonephritis. Nephrol Dial Transplant. 2022;37:S3.

doi:10.1093/ndt/gfac067.063

20. Cox J, Gunawan M, Wu J, et al. A Central Role of Endothelin A Receptor

Activation in Mesangial Cell -- Podocyte Crosstalk in IgA Nephropathy and

Other Mesangio-Proliferative Glomerulopathies. Glomerular Dis.

2022;2(Suppl 1):1-78. doi:10.1159/000525410

21. King A, Oballa R, Gunawan M, et al. POS-378 Selective ETA Antagonist

Atrasentan, Rapidly Reduces Albuminuria and Downregulates Intra-Renal

Pro-Inflammatory and Pro-Fibrotic Transcriptional Networks in the gddY

Mouse Model of Spontaneous IgA Nephropathy. Kidney Int Rep.

2021;6(4):S164. doi:10.1016/j.ekir.2021.03.396

22. McGrogan A, Franssen CF, de Vries CS. The Incidence of Primary

Glomerulonephritis Worldwide: A Systematic Review of the

Literature. Nephrol Dial Transplant. 2011;26(2):414-430.

doi:10.1093/ndt/gfq665

23. Xie J, Kiryluk K, Wang W, et al. Predicting Progression of IgA

Nephropathy: New Clinical Progression Risk Score. PLoS

ONE. 2012;7(6):e38904. doi:10.1371/journal.pone.0038904

24. Novartis. Novartis completes acquisition of Chinook Therapeutics.

Available

from: https://www.novartis.com/news/media-releases/novartis-completes-acq

uisition-chinook-therapeutics. Accessed May 2024.

25. Novartis. New Novartis Fabhalta(R) (iptacopan) data show clinically

meaningful and statistically significant proteinuria reduction of 38.3%

versus placebo for patients with IgA nephropathy (IgAN). Available from:

https://www.novartis.com/news/media-releases/new-novartis-fabhalta-iptacopan-data-show-clinically-meaningful-and-statistically-significant-proteinuria-reduction-383-versus-placebo-patients-iga-nephropathy-igan.

Accessed May 2024.

26. Perkovic V, Kollins D, Renfurm R, et al. WCN24-1506 Efficacy and Safety

of Iptacopan in Patients with IgA Nephropathy: Interim Results from the

Phase 3 APPLAUSE-IgAN Study. Kidney Int Rep. 2024;9(4):S506.

doi:10.1016/j.ekir.2024.02.1414

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May 25, 2024 06:15 ET (10:15 GMT)