Travere Therapeutics completes enrollment in pivotal phase III PROTECT study of sparsentan in IgA nephropathy.

 Topline efficacy data from the interim 36-week proteinuria endpoint analysis are expected in August 2021. The PROTECT Study is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled pivotal Phase III 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.