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Cybernet Data Systems Inc.

Ligand Pharmaceuticals' Partner Travere Therapeutics Reports Positive Trial Results for Sparsentan

Strategic Insights

— 1 min read

Ligand Pharmaceuticals Incorporated's partner, Travere Therapeutics, Inc., announced positive topline interim results from the ongoing pivotal Phase 3 PROTECT Study of sparsentan, an investigational product candidate for the treatment of IgA nephropathy. The study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan.

Key Takeaways:

  • The PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan.
  • Patients receiving sparsentan experienced a 49.8 percent mean reduction of proteinuria from baseline after 36 weeks, while irbesartan-treated patients experienced a 15.1 percent mean reduction (p=0.0001).
  • The study has a total of 404 patients with persistent proteinuria despite active ACE or ARB treatment, who were randomized 1:1 to receive once daily oral doses of either sparsentan or irbesartan.
  • Travere is providing limited data from the interim analyses to maintain integrity in the ongoing study.
  • The study protocol provided for an unblinded analysis to evaluate the interim efficacy endpoint - the change in proteinuria (urine protein-to-creatinine ratio, or "UPCR") at Week 36 from baseline - following the first approximately 280 patients reaching 36 weeks of treatment.
  • The secondary endpoints of the PROTECT Study include the rate of change in estimated glomerular filtration rate ("eGFR") following the initiation of randomized treatment over 58-week and 110-week periods.
  • Topline results from the confirmatory endpoint analysis are expected in the second half of 2023.
  • A preliminary review of the interim safety results indicate sparsentan has been generally well-tolerated and consistent with the previously observed safety profile with no new safety signals emerging.

Statistics:

  • 404 patients with persistent proteinuria despite active ACE or ARB treatment were enrolled in the PROTECT Study.
  • The study has a 1:1 randomization ratio between sparsentan and irbesartan-treated patients.
  • The interim analysis included results from the first approximately 280 patients reaching 36 weeks of treatment.
  • 49.8 percent mean reduction of proteinuria from baseline after 36 weeks was observed in sparsentan-treated patients.
  • 15.1 percent mean reduction of proteinuria from baseline after 36 weeks was observed in irbesartan-treated patients (p=0.0001).
  • Topline results from the confirmatory endpoint analysis are expected in the second half of 2023.

Sources:

  • (EDGAR Online via COMTEX) -- 0000886163false00008861632021-08-162021-08-16

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