Travere Therapeutics Announces Results from DUPLEX Study in FSGS

KING OF PRUSSIA, Pa. (MAY 2, 2023) — Travere Therape­­utics announced Monday results from their Phase 3 DUPLEX Study, which tests the drug sparsentan in focal segmental glomerulosclerosis (FSGS) patients. While the DUPLEX Study did not achieve its primary endpoint goal for eGFR, the results of its secondary endpoints provide encouragement.

At the end of the 108-week long study, the eGFR total slope compared to the control drug, irbesartan, did not reach its goals to show statistical significance. However, the results also showed:

  • An average of 50% reduction in proteinuria during the treatment.
  • More than 2x greater remission rate — 18% of patients on sparsentan achieved complete remission, vs. only 7% on irbesartan.

The results from the DUPLEX Study also indicated that sparsentan was well-tolerated, with a consistent safety profile comparable to irbesartan. Additionally, patients anecdotally reported a reduction in edema (more information on this to come as additional data is published).

“FSGS is a particularly aggressive form of kidney disease that currently does not have any FDA-approved treatments. There is a high unmet need for treatment options for those affected by FSGS. Ensuring patients have choices about the medications they take is of the utmost importance,” said Josh Tarnoff, NephCure’s CEO. “NephCure has always stressed the significance of stopping the disease and reducing protein in the urine — and sparsentan is showing to do that based on these results.”

According to Travere Therapeutics, the company will continue to explore a potential path forward with the FDA for a New Drug Application (NDA). To learn more about the DUPLEX Study results, read Travere’s press release here.

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