Travere Therapeutics Highlights FILSPARI® (Sparsentan) Benefits in IgAN and FSGS at ASN Kidney Week 2024

Travere Therapeutics, Inc., recently showcased new data demonstrating the clinical efficacy of FILSPARI (sparsentan) in treating IgA nephropathy (IgAN) and its promising potential for focal segmental glomerulosclerosis (FSGS) at the American Society of Nephrology (ASN) Kidney Week 2024. The presented findings highlighted the significant benefits of FILSPARI across various patient subgroups.

In the SPARTAN Study, nearly 60% of newly diagnosed IgAN patients achieved complete remission when treated with FILSPARI as a first-line therapy. Furthermore, the study indicated that FILSPARI led to a rapid and sustained reduction in proteinuria by approximately 70% from baseline over 24 weeks. Throughout this period, patients maintained stable estimated glomerular filtration rates.

The SPARTACUS Study and the PROTECT open-label extension provided additional insights. Interim data from the SPARTACUS Study showed that FILSPARI, when combined with stable SGLT2 inhibitors, was generally well tolerated. Approximately one-third of the patients experienced a 50% reduction in proteinuria, and two-thirds saw a 30% reduction after 24 weeks of treatment. The ongoing PROTECT Study revealed favorable safety and additive efficacy results when SGLT2 inhibitors or immunosuppressants were combined with FILSPARI.

In a late-breaking presentation, the DUPLEX Study highlighted the effectiveness of sparsentan in a subset of patients with genetic mutations associated with FSGS. This subset, often resistant to treatment, showed a significant reduction in proteinuria and long-term kidney health benefits. Additionally, patient-reported outcomes from 306 adult participants indicated stable health-related quality of life over the two-year treatment period, with a noted improvement in kidney disease burden compared to those receiving irbesartan.

Preliminary data from the EPPIK Study also underscored the potential of sparsentan in pediatric patients. Children with various rare proteinuric glomerular diseases treated with sparsentan experienced a notable reduction in proteinuria by approximately 50% over 12 weeks.

IgA nephropathy (IgAN), also known as Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA) in the kidneys. This accumulation leads to issues such as blood in the urine (hematuria), protein in the urine (proteinuria), and a gradual loss of kidney function. Other symptoms include swelling (edema) and high blood pressure. IgAN is the most common type of primary glomerulonephritis globally and a leading cause of kidney failure due to glomerular disease. It affects up to 150,000 people in the U.S. and is prevalent in Europe and Japan.

Focal segmental glomerulosclerosis (FSGS) is another rare proteinuric kidney disorder affecting both children and adults, with more than 40,000 patients in the U.S. and similar prevalence in Europe. Defined by progressive scarring of the kidney, FSGS often leads to kidney failure. Common symptoms include proteinuria, swelling (edema), low blood albumin levels, abnormal lipid profiles, and hypertension. Currently, there is no approved pharmacologic treatment for FSGS, and sparsentan is not yet approved for use in this condition.

Travere Therapeutics is dedicated to developing treatments for rare diseases. Their global team collaborates with the rare disease community to identify, develop, and deliver life-changing therapies. The company continuously seeks to understand the diverse perspectives of rare disease patients and strives to make a significant impact on their lives.

FILSPARI is currently indicated in the U.S. to slow the decline of kidney function in adults with primary IgAN who are at risk for disease progression. The safety profile of FILSPARI includes risks of hepatotoxicity and embryo-fetal toxicity, necessitating enrollment in the FILSPARI REMS program for prescribers, patients, and pharmacies.

In summary, the recent data presented by Travere Therapeutics highlight FILSPARI's potential in treating IgAN and FSGS, offering hope for patients suffering from these challenging kidney diseases.