Travere Therapeutics to present data from clinical studies of sparsentan

Travere Therapeutics announced additional data from two pivotal clinical studies demonstrating sparsentan has the potential to preserve kidney function and significantly delay time to kidney failure compared to an active comparator, suggesting long-term benefits in IgA nephropathy and focal segmental glomerulosclerosis. Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology Kidney Week 2023 and simultaneously published in The Lancet and The New England Journal of Medicine. Key Findings from the Two-Year PROTECT Study in IgAN: Treatment with FILSPARI resulted in one of the slowest rates of kidney function decline in an IgAN trial of its kind. The absolute overall change in kidney function from baseline to the end of the study for patients treated with FILSPARI was -5.8 mL/min/1.73m2 compared to -9.5 mL/min/1.73m2 with irbesartan. This translates into a 3.7 mL/min/1.73m2 higher eGFR at two years with FILSPARI compared to irbesartan. This beneficial effect on preserving kidney function was durable post washout. Treatment effects on eGFR slope were consistent across baseline eGFR and proteinuria, supporting the potential for FILSPARI as a foundational treatment option across different stages of disease. When imbalances between treatment arms were factored into pre-specified eGFR analyses the beneficial effects of FILSPARI on kidney function preservation were strengthened. Treatment with FILSPARI demonstrated lower rates of the composite endpoint of 40% decline in eGFR, kidney failure or death compared to irbesartan. Treatment with FILSPARI resulted in the largest magnitude of sustained reduction in proteinuria shown in a pivotal trial over two years with FILSPARI-treated patients achieving a mean reduction in proteinuria from baseline of 43% compared to 4% for irbesartan-treated patients. More patients treated with FILSPARI achieved complete remission of proteinuria of less than 0.3 grams compared to those treated with irbesartan. FILSPARI was well-tolerated with a safety profile that was consistent across all clinical trials conducted to date and comparable to the active control, irbesartan, including no drug-induced liver injury and no fluid overload. Key Findings from the Two-Year DUPLEX Study in FSGS: Treatment with sparsentan demonstrated a clinically meaningful and durable reduction in proteinuria, with FSGS patients achieving a 50% reduction from baseline, compared to a 32% reduction with the active control irbesartan. Sparsentan showed a consistent and sustained achievement of complete remission of proteinuria in 18.5% of patients on sparsentan vs. 7.5% for irbesartan. The combined hard endpoints of confirmed 50% reduction in eGFR, end-stage renal disease or death, trended in favor of sparsentan with fewer patients progressing to kidney failure. Sparsentan was well-tolerated with a safety profile that was consistent across all clinical trials conducted to date and comparable to the active control, irbesartan, including no drug-induced liver injury and no fluid overload.