- Compared to the active control irbesartan, the study met its pre-specified interim primary efficacy endpoint, demonstrating a more than threefold reduction of proteinuria from baseline after 36 weeks of treatment.
- After 36 weeks of treatment, patients receiving sparsentan achieved a mean reduction in proteinuria from a baseline of 49.8%, compared to 15.1% for irbesartan-treated patients.
- Preliminary estimated glomerular filtration rate (eGFR) data indicate a potentially clinically meaningful treatment effect after two years of treatment.
- Topline results from the confirmatory endpoint analysis are expected in 2H of 2023.
- Travere Therapeutics remains on track to provide a regulatory update on its Phase 3 DUPLEX Study of sparsentan for focal segmental glomerulosclerosis (FSGS) treatment during Q3 of 2021.
- The Company plans to apply for accelerated approval in the U.S. in 1H of 2022. Also, it intends to apply for conditional marketing authorization in Europe.
- Price Action: TVTX shares are up 13.7% at $17.56 during the premarket session on the last check Monday.
- Related content: Benzinga's Full FDA Calendar.
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