LGND - Ligand and Travere announce promising data from late-stage sparsentan trial
Ligand Pharma ([[LGND]] -5.4%) and partner Travere Therapeutics ([[TVTX]] +14.0%) announces 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.Preliminary results show that sparsentan has been generally well-tolerated and has shown a comparable safety profile to irbesartan.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.Under Ligand’s license agreement with Travere for sparsentan, Ligand is entitled to receive a net $5.9M milestone on NDA submission.The confirmatory primary endpoint of the DUPLEX Study is the rate of change in estimated glomerular filtration rate over 108 weeks of treatment.The DUPLEX Study is fully enrolled, and topline results from the confirmatory endpoint are expected in the first half of 2023.
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Ligand and Travere announce promising data from late-stage sparsentan trial