Today, Novartis announced that its potential "first-in-class" oral factor B inhibitor iptacopan (LNP023) has reached its primary clinical endpoint in a phase 2 clinical trial for the treatment of patients with C3 glomerulopathy (C3G).
Significantly reduce the patient's proteinuria level
.
Novartis has been actively recruiting patients for pivotal Phase 3 clinical trials
.
The press release pointed out that iptacopan is expected to become the first targeted therapy for the treatment of C3G patients
.
C3G is a rare and severe form of primary glomerulonephritis, which is characterized by complement disorders
.
About 50% of patients progress to end-stage renal disease (ESRD) within 10 years, and 50-70% of patients have disease recurrence after kidney transplantation
.
Iptacopan is an oral specific alternative complement pathway factor B inhibitor
.
It may treat diseases caused by abnormal functions of multiple alternative pathways, while not affecting the immune response to microbial invasion mediated by other complement pathways, and reducing the risk of infection for patients
.
▲Factor B inhibitors can be used to treat a variety of complement-driven nephropathy (picture source: Novartis official website)
In this phase 2 clinical trial of two patient cohorts, C3G patients who had not yet received a kidney transplant had a 45% reduction in proteinuria level compared with baseline after 12 weeks of treatment with iptacopan (p=0.
0003)
.
In the cohort of patients who received kidney transplantation but C3G recurrence, iptacopan significantly reduced the deposition of complement C3 protein in the kidney (p=0.
0313)
.
In addition, both patient cohorts showed persistent and strong inhibition of alternative complement pathway activity
.
Based on the data from the two patient cohorts, renal function remained stable after 12 weeks
.
Reference materials:
[1] Novartis iptacopan meets primary endpoints in Phase II study in rare kidney disease C3 glomerulopathy (C3G).
Retrieved November 4, 2021, from https:// -endpoints-in-phase-ii-study-in-rare-kidney-disease-c3-glomerulopathy-c3g-301416937.
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