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Travere Therapeutics Announces Late-Breaking Data from Phase 3 DUPLEX Study of FILSPARI in FSGS Presented at the American Society of Nephrology (ASN) Kidney Week 2025
Businesswireยท 2025-11-06 16:00
Core Insights - Travere Therapeutics announced late-breaking data from the Phase 3 DUPLEX Study, showing that FILSPARI (sparsentan) significantly improved proteinuria outcomes in patients with focal segmental glomerulosclerosis (FSGS) compared to irbesartan [1][2][3] Study Findings - In the DUPLEX Study, 37.5% of patients treated with FILSPARI achieved a urine protein-to-creatinine ratio (UPCR) below 0.7 g/g, compared to 21.4% for those on irbesartan, indicating a relative risk (RR) of 1.8 [3] - At week 108, 19% of FILSPARI-treated patients reached the UPCR threshold versus 11.2% for irbesartan, with an RR of 1.7 [3] - Patients achieving UPCR below 0.7 g/g had a lower likelihood of reaching kidney failure (3.6% vs. 11.2%, RR 0.52) [3][4] Long-term Risk Analysis - In the DUPLEX-aligned RaDaR cohort, achieving UPCR below 0.7 g/g at 24 months was linked to a significantly lower risk of kidney failure over an additional 60 months (hazard ratio [HR] 0.14) [4] - A similar lower risk was observed for patients who achieved UPCR below 0.7 g/g at any time during the 24-month period (HR 0.27) [4] - The analysis indicated that a 26% relative reduction in UPCR for FILSPARI-treated patients correlates to a 24% reduction in the 5-year risk of kidney failure (HR 0.76) [8] Background on FSGS - FSGS is a rare kidney disorder affecting over 40,000 patients in the U.S., characterized by progressive scarring and often leading to kidney failure [7] - There are currently no FDA-approved pharmacologic therapies specifically for FSGS [7] Company Overview - Travere Therapeutics is focused on developing therapies for rare diseases, with FILSPARI currently indicated for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) [9][28]