other material
confidence high
sentiment negative
materiality 0.80
Travere's sparsentan misses primary eGFR endpoint in Phase 3 FSGS study; proteinuria trends favorable
Travere Therapeutics, Inc.
- eGFR total slope difference 0.3 mL/min/1.73m2/yr favoring sparsentan (p=0.7491), not statistically significant.
- eGFR chronic slope difference 0.9 mL/min/1.73m2/yr (p=0.4203), also not significant.
- Proteinuria reduced 50% with sparsentan vs 32% with irbesartan at week 108; FPRE 38% vs 23%.
- Company plans to engage FDA and EMA to explore potential path for regulatory submission.
- Sparsentan well-tolerated with safety profile comparable to irbesartan through 108 weeks.