TVTX - Travere Therapeutics to Present Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023 | Benzinga
Two late-breaking high-impact oral presentations of the Phase 3 PROTECT Study of FILSPARI® (sparsentan) in IgAN and Phase 3 DUPLEX Study of sparsentan in FSGS
11 total abstracts accepted for presentation highlight Travere's leadership and commitment in the field of rare kidney disease
SAN DIEGO, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ:TVTX) today announced that the Company will present 11 abstracts, including two late-breaking oral presentations, at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 2-5, 2023.
Presentations will highlight the long-term efficacy and tolerability data of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) from the PROTECT Study, as well as the potential for use of FILSPARI as a first-line treatment in newly diagnosed IgAN patients and in combination with SGLT2 inhibitors. The Company will also present data on the efficacy and tolerability of sparsentan in focal segmental glomerulosclerosis (FSGS) and pediatric proteinuric glomerular diseases, as well as provide insights into patient quality of life and the impact of proteinuria on kidney survival in rare kidney diseases.
"The data we and our collaborators are presenting at ASN are a testament to our collective dedication to enhance our scientific understanding of kidney diseases to improve patients' lives," said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. "We look forward to presenting data that further demonstrate the clinical benefit of sparsentan in rare kidney diseases and sharing important advancements that have the potential to shape the future of patient care."
Late-Breaker Oral Presentations
Sparsentan vs Irbesartan in Patients with Focal Segmental Glomerulosclerosis (FSGS): Results from the Phase 3 DUPLEX Trial
Abstract: FR-OR108
Oral Abstract Session: High Impact Clinical Trials
Hall A; November 3, 10:30-10:45 a.m. ET
Pivotal Results of the Phase 3 PROTECT Trial of Sparsentan vs Irbesartan in Patients with Immunoglobulin A Nephropathy (IgAN)
Abstract: FR-OR109
Oral Abstract Session: High Impact Clinical Trials
Hall A; November 3, 10:45-11:00 a.m. ET
Oral Presentation
Preliminary Findings from the Phase 2 EPPIK Study of Sparsentan in Pediatric Patients with Selected Proteinuric Glomerular Diseases
Abstract: SA-OR84
Oral Abstract Session: Pediatric Nephrology: Clinical and Genetic Studies
Room 105; November 4, 5:24-5:33 p.m. ET
Poster Presentations
Humanistic Burden of Rare Kidney Diseases: Understanding the Impact of IgAN and FSGS on Patients & Care-partners Study (HONUS): Preliminary Results for FSGS in the United States (US)
Poster: TH-PO597
Poster Session: Glomerular Diseases: Clinical and Epidemiologic Studies
Exhibit Hall; November 2, 10:00 a.m.-12:00 p.m. ET
Predictors of Major Adverse Kidney Disease Events in a Real-world Population with IgA Nephropathy
Poster: TH-PO614
Poster Session: Glomerular Diseases: Clinical and Epidemiologic Studies
Exhibit Hall; November 2, 10:00 a.m.-12:00 p.m. ET
Comparing Proteinuria and Kidney Survival in FSGS and IgAN: A NEPTUNE Analysis
Poster: TH-PO622
Poster Session: Glomerular Diseases: Clinical and Epidemiologic Studies
Exhibit Hall; November 2, 10:00 a.m.-12:00 p.m. ET
Sparsentan as First-line Treatment of Incident Patients with IgA Nephropathy: Preliminary Findings from the SPARTAN Trial
Poster: SA-PO901
Poster Session: Glomerular Diseases: Therapeutics
Exhibit Hall; November 4, 10:00 a.m.-12:00 p.m. ET
Sparsentan Receptor Occupancy Modeling, Clinical Actions, and Safety
Poster: SA-PO276
Poster Session: Pharmacology: Kinetics, Genomics, Medication-Related Problems
Exhibit Hall; November 4, 10:00 a.m.-12:00 p.m. ET
Concomitant Sparsentan and Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) in Patients with IgA Nephropathy (IgAN) in the PROTECT Open-label Extension (OLE)
Poster: SA-PO903
Poster Session: Glomerular Diseases: Therapeutics
Exhibit Hall; November 4, 10:00 a.m.-12:00 p.m. ET
Rate of Loss of eGFR and Time-averaged Proteinuria in IgAN Patients Progressing from Early Stage Disease to Kidney Failure
Poster: SA-PO948
Poster Session: Glomerular Diseases: Translational Studies and Biomarkers
Exhibit Hall; November 4, 10:00 a.m.-12:00 p.m. ET
Sparsentan and Sodium-glucose Cotransporter 2 Inhibitors (SGLT2i) in the PROTECT Open-label extension (OLE) Substudy and SPARTACUS: Trials in Progress
Poster: SA-PO902
Poster Session: Glomerular Diseases: Therapeutics
Exhibit Hall; November 4, 10:00 a.m.-12:00 p.m. ET
About IgA Nephropathy
IgA nephropathy (IgAN), also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Other symptoms of IgAN may include swelling (edema) and high blood pressure.
IgAN is the most common type of primary glomerulonephritis worldwide and a leading cause of kidney failure due to glomerular disease. IgAN is estimated to affect up to 150,000 people in the U.S. and is one of the most common glomerular diseases in Europe and Japan.
About Focal Segmental Glomerulosclerosis
Focal segmental glomerulosclerosis (FSGS) is a rare proteinuric kidney disorder in both children and adults that is estimated to affect more than 40,000 patients in the US with similar prevalence in Europe. The disorder is defined by progressive scarring of the kidney and often leads to kidney failure. FSGS is characterized by proteinuria, where protein leaks into the urine due to a breakdown of the normal filtration mechanism in the kidney. Once in the urine, protein is considered to be toxic to other parts of the kidney, especially the tubules, and is believed to contribute to further disease progression. Other common symptoms include swelling in parts of the body, known as edema, as well as low blood albumin levels, abnormal lipid profiles and hypertension. There is currently no approved pharmacologic indicated for the treatment of FSGS.
About the PROTECT Study
The PROTECT Study is one of the largest interventional studies to date in IgA nephropathy (IgAN) and the only head-to-head trial in this rare kidney disease. It is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled clinical trial evaluating the safety and efficacy of 400 mg of sparsentan, compared to 300 mg of irbesartan, in 404 patients ages 18 years and up with IgAN and persistent proteinuria despite receiving at least 50% of max label dose and maximally tolerated ACE or ARB therapy. In August 2021, the Company announced the PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance. Based on the pre-specified, primary analyses set, after 36 weeks of treatment, patients receiving sparsentan achieved a mean reduction in proteinuria from baseline of 49.8%, compared to a mean reduction in proteinuria from baseline of 15.1% for irbesartan-treated patients (p<0.0001). The study's confirmatory secondary endpoint in the U.S. is eGFR total slope from day 1 to week 110 of treatment. The confirmatory secondary endpoint in ...