Data support the Company’s lead investigational product candidate sparsentan
SAN DIEGO, Oct. 26, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company and its collaborators will present data from its sparsentan programs, including long-term clinical data from the ongoing Phase 2 DUET Study in focal segmental glomerulosclerosis (FSGS), as well as non-clinical data exploring the potential for sparsentan to protect kidney function at the American Society of Nephrology (ASN) Kidney Week 2022. The company will also present data on the role of proteinuria in IgA nephropathy (IgAN) and on the humanistic burden of IgAN on patients and caregivers. ASN Kidney Week 2022 is being held November 3-6, 2022, in Orlando, Florida.
Oral Presentations
Sparsentan Improves Glomerular Endothelial and Podocyte Functions and Augments Protective Tissue Repair in a Mouse Model of Focal Segmental Glomerulosclerosis (FSGS) Session: Glomerular Diseases: From Bench to BedsideOral Presentation: FR-OR56Location: Session Room: W414 (Orange County Convention Center, West Building)Date & Time: November 4, 2022, from 5:15 to 5:24 p.m. ET
Long-Term Efficacy and Safety of Sparsentan in FSGS: 240-Week Analysis of the DUET Open-Label Extension (OLE)Session: Glomerular Diseases: From Bench to BedsideOral Presentation: FR-OR57 Location: W414 (Orange County Convention Center, West Building) Date & Time: November 4, from 5:24 to 5:33 p.m. ET
Poster Presentations
Evaluating the Predictors of Structural Features in Kidney Biopsies from Adults with Focal Segmental Glomerulosclerosis Poster #: TH-PO478Session: Glomerular Diseases: Clinical, Outcomes, Trials – IDate, Time & Location: November 3, 2022, from 10 a.m. to 12 p.m. ET, Hall E
Proteinuria and Its Association With Disease Progression in IgA Nephropathy: Analysis of the UK National RaDaR IgA Nephropathy Cohort Poster #: TH-PO494 Session: Glomerular Diseases: Clinical, Outcomes, Trials - I Date, Time & Location: November 3, 2022, from 10 a.m. to 12 p.m. ET, Hall E
Health State Utility Values for Immunoglobulin A Nephropathy (IgAN) Poster #: TH-PO496Session: Glomerular Diseases: Clinical, Outcomes, Trials – IDate, Time & Location: November 3, 2022, from 10 a.m. to 12 p.m. ET, Hall E
Effect of Multiple Doses of Sparsentan on the Single-Dose Pharmacokinetics of Dapagliflozin: Open-Label Drug-Drug Interaction Study in Healthy Adults Poster #: FR-PO217 Session Title: Pharmacology Date, Time & Location: November 4, 10 a.m. to 12 p.m. ET, Hall E
Predictors of Progression to Kidney Failure in Patients with Focal Segmental Glomerulosclerosis Poster #: FR-PO662Session: Glomerular Diseases: Clinical, Outcomes, Trials - II Date, Time & Location: November 4, 10 a.m. to 12 p.m. ET, Hall E
Development of a Treatment Response Prediction Strategy for Sparsentan in Glomerular Disease Poster #: FR-PO724Session: Glomerular Diseases: Podocyte Biology – IDate, Time & Location: November 4, 10 a.m. to 12 p.m. ET, Hall E
Differentiating Primary and Secondary FSGS Using Non-Invasive Urine Biomarkers Poster #: FR-PO913Session: CKD: Epidemiology, Risk Factors, Prevention – IIDate, Time & Location: November 4, 10 a.m. to 12 p.m. ET, Hall E
Humanistic Burden of Patients with Immunoglobulin A Nephropathy (IgAN) in the United States (US): Preliminary Results from HONUS Study Poster Board #: SA-PO699Session: Glomerular Diseases: Clinical, Outcomes, Trials - III Date, Time & Location: November 5, 2022, from 10 a.m. to 12 p.m. ET, Hall E
A Retrospective Analysis of Cardiovascular Disease (CVD) Events in Prevalent Patients with Focal Segmental Glomerulosclerosis (FSGS) in the USPoster #: SA-PO702 Session: Glomerular Diseases: Clinical, Outcomes, Trials - IIIDate, Time & Location: November 5, 2022, from 10 a.m. to 12 p.m. ET, Hall E
About Sparsentan
Sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is a novel investigational product candidate selectively targeting the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). Pre-clinical data have shown that blockade of both endothelin type A and angiotensin II type 1 pathways in forms of rare chronic kidney disease, reduces proteinuria, protects podocytes and prevents glomerulosclerosis and mesangial cell proliferation. Sparsentan has been granted Orphan Drug Designation for the treatment of FSGS and IgAN in the U.S. and Europe.
Sparsentan is currently being evaluated in the pivotal Phase 3 DUPLEX Study for the treatment of FSGS and the pivotal Phase 3 PROTECT Study for the treatment of IgAN. In February 2021, the Company announced that the ongoing pivotal Phase 3 DUPLEX Study of sparsentan in FSGS achieved its pre-specified interim FSGS partial remission of proteinuria endpoint (FPRE) with statistical significance. FPRE is a clinically meaningful endpoint defined as urine protein-to-creatinine ratio (UP/C) ≤1.5 g/g and a >40 percent reduction in UP/C from baseline. 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). Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and shown a comparable safety profile to irbesartan. In August of 2021, the Company announced that the ongoing PROTECT Study in IgAN met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan (p