- Travere Therapeutics Inc (NASDAQ: TVTX) share gains after announcing positive interim results from the ongoing Phase 3 DUPLEX study evaluating sparsentan in focal segmental glomerulosclerosis (FSGS), a rare kidney condition that often leads to end-stage kidney disease.
- The study achieved its pre-specified interim FSGS partial remission of proteinuria endpoint (FPRE) after 36 weeks of sparsentan treatment. It demonstrated a statistically significant response compared to the active control, irbesartan. Proteinuria is defined as a reduction in protein in urine from baseline.
- Preliminary results show that sparsentan has generally been well-tolerated and demonstrated a comparable safety profile to Sanofi's irbesartan.
- The Company plans to continue its engagement with regulators in the first half of 2021 to discuss the ongoing study and establish the next steps to file with the available data set.
- The DUPLEX study's confirmatory endpoint is the change in the slope of estimated glomerular filtration rate (eGFR), a measure of kidney function, from baseline after 108 weeks of treatment. The study is fully enrolled, with topline results from the confirmatory endpoint expected in the first half of 2023.
- Sparsentan is also being evaluated for IgA nephropathy in Phase 3 PROTECT study, and topline efficacy data from the 36-week interim proteinuria endpoint analysis is anticipated in Q3 of this year.
- See TVTX conference call and webcast discussing the interim results.
- Price Action: TVTX shares gained 19% at $30.80 in premarket trading on the last check Tuesday.
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