Travere Kidney Data Reinforce Efficacy, Supporting Ongoing Launch

 

• On Saturday, Travere Therapeutics Inc 
  TVTX+0.27%+ Free Alerts
   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.
• 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.

https://www.benzinga.com/general/biotech/23/04/31628166/additional-data-from-travere-therapeutics-kidney-disease-candidate-reinforce-efficacy-supporting-