Travere Therapeutics to Present New FILSPARI Data at the 15th International Podocyte Conference

TVTX

Published on 06/12/2025 at 10:25

SAN DIEGO - Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the Company will present three abstracts on the effect of FILSPARI (sparsentan) in rare kidney disease at the upcoming International Podocyte Conference in Hamburg, Germany, June 10-13, 2025.

The Company will present new data evaluating biomarkers of disease progression in IgA nephropathy (IgAN) from the Phase 2 SPARTAN Study showing rapid and sustained reductions in urinary BAFF and sC5b9 as well as reductions in proinflammatory and profibrotic biomarkers after starting FILSPARI, suggesting disease-modifying activity.

'At the International Podocyte conference, we're pleased to present new biomarker data from the SPARTAN Study that further support the kidney targeted benefit of FILSPARI in the clinical setting,' said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. 'Together with the broader body of existing nonclinical data on FILSPARI, these findings suggest the potential for disease-modifying effects in IgA nephropathy.'

International Podocyte Conference Presentations

Urinary Biomarker Analysis Reveals Rapid Intrarenal Anti-inflammatory and Antifibrotic Effects of Sparsentan in IgA nephropathy in the SPARTAN study

Poster: FR_11

Date: Friday, 13 June

Location: Kleiner Festsaal

Time: 10:30-11:15; 12:45-14:00 CEST

Patients with Focal Segmental Glomerulosclerosis (FSGS) Achieved Low Proteinuria Targets Earlier and More Often with Sparsentan vs. Irbesartan in the DUPLEX Study

Poster: FR_26

Date: Friday, 13 June

Location: Small banquet hall

Time: 10:30-11:15; 12:45-14:00 CEST

Sparsentan Has Direct Effects on the Glomerular Capillary Wall to Attenuate Increased Permeability in Nephrotic Syndrome Models

Poster: FR_17

Date: Friday, 13 June

Location: Kleiner Festsaal

Time: 10:30-11:15; 12:45-14:00 CEST

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 children and adults that is estimated to affect more than 40,000 patients in the U.S., 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 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. Sparsentan is not approved for use in FSGS. There are currently no FDA-approved pharmacologic therapies for FSGS.

About Travere Therapeutics

At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent - that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope today and tomorrow.

Forward Looking Statements

This press release contains 'forward-looking statements' as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words 'on-track,' 'positioned,' 'look forward to,' 'will,' 'would,' 'may,' 'might,' 'believes,' 'anticipates,' 'plans,' 'expects,' 'intends,' 'potential,' or similar expressions. In addition, expressions of strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: statements relating to the clinical studies and models described herein, and data to be presented; statements and expectations regarding the kidney targeted benefit of FILSPARI in the clinical setting and the potential for disease-modifying effects in IgAN and statements related to the estimated sizes of patient populations. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties related to the Company's sNDA for FILSPARI in FSGS, including the timing and outcome thereof. There is no guarantee that the FDA will grant approval of FILSPARI for FSGS on the anticipated timeline, or at all. The Company also faces risks and uncertainties related to its business and finances in general, the success of its commercial products, risks and uncertainties associated with its preclinical and clinical stage pipeline, risks and uncertainties associated with the regulatory review and approval process, risks and uncertainties associated with enrollment of clinical trials for rare diseases, and risks that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons. Specifically, the Company faces risks associated with the ongoing commercial launch of FILSPARI in IgAN, the timing and potential outcome of its and its partners' clinical studies, market acceptance of its commercial products including efficacy, safety, price, reimbursement, and benefit over competing therapies, risks related to the challenges of manufacturing scale-up, risks associated with the successful development and execution of commercial strategies for such products, including FILSPARI, and risks and uncertainties related to the new administration, including but not limited to risks and uncertainties related to tariffs and the funding, staffing and prioritization of resources at government agencies including the FDA. The Company also faces the risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates, including as a result of macroeconomic conditions; risks relating to the Company's dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions and risks and uncertainties relating to competitive products, including current and potential future generic competition with certain of the Company's products, and technological changes that may limit demand for the Company's products. The Company also faces additional risks associated with global and macroeconomic conditions, including health epidemics and pandemics, including risks related to potential disruptions to clinical trials, commercialization activity, supply chain, and manufacturing operations. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties, including under the heading 'Risk Factors', as included in the Company's most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission.

Contact:

Tel: 888-969-7879

Email: [email protected]

Tel: 888-969-7879

Email: [email protected]

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