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Travere Therapeutics Announces Achievement of Interim Proteinuria Endpoint in the Ongoing Phase 3 DUPLEX Study of Sparsentan in Focal Segmental Glomerulosclerosis
Sparsentan achieved statistically significant response on interim proteinuria endpoint compared to irbesartan after 36-weeks of treatment To date in the
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"Sparsentan achieved statistically significant response on interim proteinuria endpoint compared to irbesartan after 36-weeks of treatment To date in the study, sparsentan has been generally well-tolerated and has shown a safety profile comparable to irbesartan Company to host conference call and webcast today at 8:30 a.m. ET SAN DIEGO, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company’s ongoing pivotal Phase 3 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. “For decades people living with FSGS have faced daily challenges in controlling proteinuria and a fear of progressing to transplant or dialysis because current treatment options are not enough,” said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics. “Today, we are very pleased to announce interim proteinuria results from the ongoing DUPLEX Study that demonstrate treatment with sparsentan can lead to significantly greater reductions in proteinuria compared to current standard of care. As we move ahead, our organization will be focused on maintaining high quality in this ongoing study, and on continuing our engagement with regulators to enable submissions for accelerated approval 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 ...