Travere Therapeutics Inc.’s stock TVTX tumbled 35% Tuesday, after the company said data from a two-year study of a kidney drug failed to show a statistically significant improvement. The company said the Phase 3 trial of Sparsentan as a treatment for focal segmental glomerulosclerosis, or FSGS, did not meet the primary efficacy eGFR slope endpoint over 108 weeks of treatment. The eGFR slope is used to measure renal function. FSGS is a disease that causes scarring of the kidneys and is a common cause of acquired glomerular disease leading to end stage kidney disease. It’s estimated to affect more than 40,000 patients in the U.S. The trial involved 371 patients. The company is now planning to explore a path forward with regulators for a supplemental New Drug Application in the U.S. “We are disappointed that we did not achieve the primary efficacy endpoint in this study, but we did see results that trended favorably for sparsentan that we are further exploring to determine a potential path forward in FSGS,” said Dr. Eric Dube, CEO of Travere.
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