Benzinga | Jun 2, 2021 08:08AM EDT

Travere Therapeutics Says Completes Enrollment In Pivotal Phase 3 PROTECT Study Of Sparsentan In IgA Nephropathy

Travere Therapeutics, Inc. (NASDAQ:TVTX) today announced completion of patient enrollment in the Phase 3 PROTECT Study. The pivotal PROTECT Study is evaluating the safety and efficacy of sparsentan for the treatment of IgA nephropathy (IgAN), a rare kidney disorder that often progresses to end-stage kidney disease (ESKD). Topline efficacy data from the interim 36-week proteinuria endpoint analysis are expected in August 2021.



"The current treatment goal for people living with IgAN is to preserve kidney function, but with limited treatment options available many patients remain at high risk of progression towards end-stage kidney disease," said Noah Rosenberg, M.D., chief medical officer of Travere Therapeutics. "Completing enrollment in PROTECT marks a significant milestone on our path to potentially establishing sparsentan, if approved, as a new, non-immunosuppressant based treatment option to slow the progression of IgAN. We are grateful for the continued strong support from patients and investigators in this important trial, and we look forward to the topline results from the 36-week proteinuria analysis in August of this year."

The PROTECT Study is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled pivotal Phase 3 clinical trial evaluating the safety and efficacy of sparsentan in approximately 380 patients with IgAN. The PROTECT Study protocol provides for an unblinded analysis of at least 280 patients to be performed after 36 weeks of treatment to evaluate the primary efficacy endpoint -- the change in proteinuria (urine protein-to-creatinine ratio, or UPCR) at Week 36 from baseline. The interim assessment of the PROTECT Study is designed to support potential submissions under the Subpart H pathway for accelerated approval in the United States, and potential Conditional Marketing Authorization in Europe. Secondary efficacy endpoints include the rate of change in eGFR following the initiation of randomized treatment over 58-week and 110-week periods, as well as the rate of change in eGFR over 52-week and 104-week periods following the first six weeks of randomized treatment in approximately 380 patients.