Travere Therapeutics announces achievement of interim proteinuria endpoint in the phase III DUPLEX study of sparsentan for focal segmental glomerulosclerosis.

Travere Therapeutics, Inc. announced that the Company’s ongoing pivotal Phase III DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS) achieved its pre-specified interim FSGS partial remission of proteinuria endpoint (FPRE) after 36 weeks of treatment. Sparsentan, an investigational product candidate, demonstrated a statistically significant response on FPRE compared to the active control, irbesartan (p=0.0094). Preliminary results from the interim analysis suggest that to date in the study, sparsentan has been generally well-tolerated and has shown a comparable safety profile to irbesartan. Based on the data from the interim analysis, the Company intends to pursue submissions for accelerated approval of sparsentan for FSGS. The Company plans to continue its engagement with regulators in the first half of 2021 to discuss the ongoing study and to establish next steps for filing with the available data set. Consistent with prior guidance, the Company is providing limited data from the interim analyses to maintain trial integrity in the ongoing study. In the DUPLEX Study , a total of 371 patients were randomized 1:1 to receive either sparsentan or irbesartan, the active control. The study protocol provided for an unblinded analysis to evaluate the interim efficacy endpoint – the proportion of patients achieving FPRE, which is a clinically meaningful endpoint defined as urine protein-to-creatinine ratio (UP/C) less then 1.5 g/g and a greater than 40 percent reduction in UP/C from Baseline, at Week 36 – following the first approximately 190 patients reaching 36 weeks of treatment. After 36 weeks of treatment, 42.0 percent of patients receiving sparsentan achieved FPRE, compared to 26.0 percent of irbesartan-treated patients (p=0.0094). The confirmatory primary endpoint of the DUPLEX Study to support full regulatory approval is the rate of change in eGFR over 108 weeks of treatment. As of the time of the interim analyses, available long-term eGFR data for the confirmatory endpoint were limited. Consistent with the DUPLEX Study protocol, patients will continue in a blinded manner to assess the treatment effect on eGFR slope over 108 weeks in the confirmatory endpoint analysis. A preliminary review of the interim safety results indicate sparsentan has been generally well-tolerated and the overall safety profiles in the study to date have been generally comparable between treatment groups..