Previously presented data from the long-term extension study (NCT03955445) showed kidney function was maintained in the seven patients that were treated for a total of six months at that time, suggesting extended iptacopan treatment may prolong the time to, or even potentially prevent, the development of kidney failure 5,6. In combined data from both cohorts, kidney function remained stable after 12 weeks, as assessed by estimated glomerular filtration rate (eGFR, average increase of 1.04 mL/min compared to baseline) 1. "These results are important for patients with C3G because proteinuria is a key risk predictor for kidney disease progression, and deposits of C3 protein ultimately cause inflammation and kidney damage."Īdditionally, both cohorts of this Phase II study showed strong and sustained inhibition of alternative complement pathway activity and normalization of serum C3 levels over 12 weeks 1. "The data presented at ASN provide a detailed picture of the potential of iptacopan for the treatment of patients with C3G and, for the first time, in patients whose C3G had returned following kidney transplantation," said lead study investigator Edwin Wong, Consultant Nephrologist at the National Renal Complement Therapeutics Centre, Newcastle upon Tyne NHS Foundation Trust, Newcastle University, UK.
Patients in cohort B (7* whose C3G had returned following a kidney transplant) showed significantly reduced C3 protein deposits compared to baseline, as measured by C3 deposit score (based on immunofluorescence microscopy) from kidney biopsy (P=0.0313) 1. Patients in cohort A (16 with C3G, but who have not had a kidney transplant ) showed a significant 45% reduction in proteinuria (protein in urine) compared to baseline, as measured by 24-hour urinary protein to creatine ratio (UPCR 24h P=0.0003) 1. In the final analysis from the open-label, two-cohort Phase II study (NCT03832114), patients were treated with 200mg of iptacopan twice daily for 12 weeks, in addition to background therapy 1. The data were presented at the American Society of Nephrology (ASN) 2021 Annual Meeting. 4, 2021 /PRNewswire/ - Novartis today announced that a Phase II study of investigational iptacopan (LNP023) – a first-in-class, oral, selective factor B inhibitor – in patients with C3 glomerulopathy (C3G) met primary endpoints in both patient cohorts 1. Novartis is rapidly advancing clinical development of iptacopan to potentially address several complement-driven renal diseases (CDRDs) with high unmet need, as part of our wider commitment to cardiovascular, renal and metabolic disease pivotal Phase III APPEAR-C3G study is actively recruitingĮAST HANOVER, N.J., Nov.
No current approved treatments exist for C3G - a rare and often progressive disease that often affects adolescents and young adults and frequently progresses to kidney failure(2-4) Additionally, statistically significant reduction in C3 protein deposits were achieved in the same study in a cohort of patients whose C3G recurred following kidney transplantation(1) Statistically significant and clinically important reductions in proteinuria were achieved for the primary endpoint for patients with C3G(1)
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