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Ligand Partner 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 Ligand Pharmaceuticals Incorporated
[{"type":"text","content":"\nSparsentan achieved statistically significant response on interim proteinuria endpoint compared to irbesartan after 36-weeks of treatment\n\nTo date in the study, sparsentan has been generally well-tolerated and has shown a safety profile comparable to irbesartan\n\n SAN DIEGO--(BUSINESS WIRE)--\nLigand Pharmaceuticals Incorporated (NASDAQ: LGND) partner Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that their 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, Travere intends to pursue submissions for accelerated approval of sparsentan for FSGS and 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.\n\nUnder Ligand’s license agreement with Travere for sparsentan, Ligand is entitled to receive a net $5.9 million milestone on NDA submission, other potential milestone payments and net royalties of 9% on future worldwide sales by Travere. The royalty term is expected to be 10 years following the first commercial sale.\n\n“Travere has reported impressive top-line results from the Sparsentan DUPLEX trial, and we commend their team for the success in this study,” said John Higgins, CEO of Ligand Pharmaceuticals. “We are proud of our partnership and the early collaborative work we did to help support this program. Sparsentan is one of Ligand’s top partnered portfolio assets, and we are very pleased to see this asset progress.”\n\n“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 fro...