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Friday, November 3, 2023

Travere Late-Breaking Data from Phase 3 Studies of Sparsentan

 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

https://www.globenewswire.com/news-release/2023/11/03/2773287/0/en/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-America.html

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