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.