Additional Data From Travere Therapeutics' Kidney Disease Candidate Reinforce Efficacy, Supporting Ongoing Launch

  • On Saturday, Travere Therapeutics Inc TVTX presented results from the interim analysis of Phase 3 PROTECT study of Filspari (sparsentan) in IgA nephropathy (IgAN) at the World Congress of Nephrology (WCN) 2023 annual meeting, and concurrently published results of the interim analysis in The Lancet
  • IgA nephropathy (IgAN), also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight kidney infections.
  • The additional details from the PROTECT interim analysis demonstrated efficacy across several measures, including changes from baseline to week 36 in urine protein-creatinine ratio (UP/C) of -49.8% for Filspari compared to -15.1% for irbesartan.
  • Related: Travere Therapeutics Scores Accelerated FDA Approval For Rare Kidney Disease Treatment.
  • Filspari also achieved significant complete (<0.3 g/day) and partial (<0.5 g/day) proteinuria remission compared to irbesartan (20.8% versus 7.9% and 70.3% versus 44.1%, respectively).
  • The PROTECT Study is fully enrolled and is scheduled to continue as planned on a blinded basis to assess the treatment effect on eGFR slope over 110 weeks in the confirmatory endpoint analysis. 
  • Topline results from the confirmatory endpoint analysis are expected in the fourth quarter of 2023.
  • Price Action: TVTX shares closed higher by 1.81% at $22.49 on Friday.
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