Travere tanks as Phase III study of Filspari just misses endpoint

Shares of Travere Therapeutics (Nasdaq: TVTX) plunged more than 40% to $7.65 yesterday after it released top-line two-year confirmatory secondary endpoint results from the pivotal head-to-head Phase III PROTECT study of Filspari (sparsentan) in IgA nephropathy (IgAN), which narrowly missed eGFR total slope endpoint compare to irbesartan.

The PROTECT study results add to earlier disappointing data from the Phase III DUPLEX study of sparsentan in focal segmental glomerulosclerosis (FSGS), a devastating kidney disease.

However, Travers noted that Filspari demonstrated long-term kidney function preservation and achieved a clinically meaningful difference in estimated glomerular filtration rate (eGFR) total and chronic slope versus irbesartan, narrowly missing statistical significance in eGFR total slope while achieving statistical significance in eGFR chronic slope for purposes of regulatory review in the EU.