Travere therapeutics announces topline results from two-year primary efficacy endpoint in pivotal phase 3 duplex study of sparsentan in focal segmental glomerulosclerosis
The duplex study did not achieve the primary efficacy egfr slope endpoint over 108 weeks of treatment secondary and topline exploratory endpoints trended favorably for sparsentan treatment with sparsentan resulted in a reduction of proteinuria that was sustained through 108 weeks of treatment sparsentan was well-tolerated with a consistent safety profile across all clinical trials conducted to date and comparable to irbesartan company to host conference call and webcast today at 4:30pm et san diego, may 01, 2023 (globe newswire) -- travere therapeutics, inc. (nasdaq: tvtx) today announced topline primary efficacy results from the pivotal phase 3 duplex study of sparsentan, a dual endothelin angiotensin receptor antagonist (deara), in focal segmental glomerulosclerosis (fsgs). at the end of the 108-week double-blind period, sparsentan was observed to have a 0.3 ml/min/1.73m2 per year (95% ci: -1.74, 2.41) favorable difference on egfr total slope and a 0.9 ml/min/1.73m2 per year (95% ci: -1.27, 3.04) favorable difference on egfr chronic slope compared to the active control irbesartan, which was not statistically significant.
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