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Travere Therapeutics Announces Late-Breaking Data from Phase 3 Studies of Sparsentan in IgAN and FSGS Published in The Lancet and The NEJM Respectively and Presented at the American Society of Nephrology (ASN) Kidney Week 2023
Two-year results from both PROTECT and DUPLEX pivotal Phase 3 studies demonstrate treatment with sparsentan has the potential to preserve kidney function and
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"Two-year results from both PROTECT and DUPLEX pivotal Phase 3 studies demonstrate treatment with sparsentan has the potential to preserve kidney function and significantly delay time to kidney failure, suggesting long-term benefits in IgAN and FSGS In PROTECT, the only head-to-head study conducted to date in IgAN, FILSPARI® (sparsentan) showed one of the slowest rates of kidney function decline in IgAN trials, consistent treatment effects across baseline eGFR and proteinuria, and higher rates of complete remission compared to maximally tolerated dose of irbesartan through 110 weeks of treatment In DUPLEX, the largest interventional study in FSGS and only study against a maximally dosed active comparator, sparsentan delivered a clinically meaningful benefit at 108 weeks with significant proteinuria reduction, higher rates of partial and complete remission, and lower rates of end-stage kidney disease Sparsentan was well tolerated with a safety profile comparable to the maximally tolerated dose of irbesartan in both Phase 3 studies, including no drug-induced liver injury or fluid overload SAN DIEGO, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today 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 (IgAN) and focal segmental glomerulosclerosis (FSGS). Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet (PROTECT) and The New England Journal of Medicine (DUPLEX). “We’re proud to have set the bar very high in delivering clinically meaningful data from two of the most rigorous Phase 3 clinical trials to date in IgAN and FSGS and to now share these two-year data in prestigious peer-reviewed journals and at ASN Kidney Week,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. “These data from PROTECT suggest that FILSPARI has the potential to significantly delay time to kidney failure, which based on recently published data is projected to be an additional eight years versus being treated with standard of care.” Key Findings from the...