SAN DIEGO, Oct. 26, 2022 (GLOBE NEWSWIRE) — Travere Therapeutics, Inc. (NASDAQ: TVTX) as we speak introduced that the Company and its collaborators will current information from its sparsentan packages, together with long-term scientific information from the continuing Phase 2 DUET Study in focal segmental glomerulosclerosis (FSGS), in addition to non-clinical information exploring the potential for sparsentan to guard kidney perform at the American Society of Nephrology (ASN) Kidney Week 2022. The firm can even current information on the function of proteinuria in IgA nephropathy (IgAN) and on the humanistic burden of IgAN on sufferers 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 Bedside
Oral Presentation: FR-OR56
Location: Session Room: W414 (Orange County Convention Center, West Building)
Date & Time: November 4, 2022, from 5:15 to five: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 Bedside
Oral Presentation: FR-OR57
Location: W414 (Orange County Convention Center, West Building)
Date & Time: November 4, from 5:24 to five:33 p.m. ET
Poster Presentations
Evaluating the Predictors of Structural Features in Kidney Biopsies from Adults with Focal Segmental Glomerulosclerosis
Poster #: TH-PO478
Session: Glomerular Diseases: Clinical, Outcomes, Trials – I
Date, 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-PO496
Session: Glomerular Diseases: Clinical, Outcomes, Trials – I
Date, 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-PO662
Session: 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-PO724
Session: Glomerular Diseases: Podocyte Biology – I
Date, 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-PO913
Session: CKD: Epidemiology, Risk Factors, Prevention – II
Date, Time & Location: November 4, 10 a.m. to 12 p.m. ET, Hall E
Humanistic Burden of Patients with Immunoglobulin A Nephropathy (IgAN) within the United States (US): Preliminary Results from HONUS Study
Poster Board #: SA-PO699
Session: 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) within the US
Poster #: SA-PO702
Session: Glomerular Diseases: Clinical, Outcomes, Trials – III
Date, 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 concentrating on the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). Pre-clinical information have proven that blockade of each endothelin kind A and angiotensin II kind 1 pathways in types of uncommon power kidney illness, reduces proteinuria, protects podocytes and prevents glomerulosclerosis and mesangial cell proliferation. Sparsentan has been granted Orphan Drug Designation for the therapy of FSGS and IgAN within the U.S. and Europe.
Sparsentan is presently being evaluated within the pivotal Phase 3 DUPLEX Study for the therapy of FSGS and the pivotal Phase 3 PROTECT Study for the therapy of IgAN. In February 2021, the Company introduced that the continuing 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 significant endpoint outlined as urine protein-to-creatinine ratio (UP/C) ≤1.5 g/g and a >40 % discount in UP/C from baseline. After 36 weeks of therapy, 42.0 % of sufferers receiving sparsentan achieved FPRE, in comparison with 26.0 % of irbesartan-treated sufferers (p=0.0094). Preliminary outcomes from the interim evaluation recommend that at the time of the interim evaluation, sparsentan had been typically well-tolerated and proven a comparable security profile to irbesartan. In August of 2021, the Company introduced that the continuing PROTECT Study in IgAN met its pre-specified interim main efficacy endpoint with statistical significance, demonstrating a larger than threefold discount of proteinuria from baseline after 36 weeks of therapy, in comparison with the energetic management irbesartan (p<0.0001). Preliminary outcomes from the interim evaluation recommend that at the time of the interim evaluation, sparsentan had been typically effectively tolerated and carried out according to the noticed security profile thus far. In the Phase 2 DUET Study of sparsentan in FSGS, the mixed therapy group met its main efficacy endpoint, demonstrating a larger than two-fold discount in proteinuria in comparison with irbesartan, and was typically effectively tolerated after the eight-week, double-blind therapy interval. Irbesartan is a part of a category of medication used to handle FSGS and IgAN within the absence of an authorized pharmacologic therapy. An NDA for accelerated approval of sparsentan in IgAN is presently being evaluated by the FDA beneath Priority Review designation. If authorized for each indications, sparsentan might doubtlessly be the primary medication authorized for each FSGS and IgAN.
About Travere Therapeutics
At Travere Therapeutics, we’re in uncommon for all times. We are a biopharmaceutical firm that comes collectively day-after-day to assist sufferers, households and caregivers of all backgrounds as they navigate life with a uncommon illness. On this path, we all know the necessity for therapy choices is pressing – that’s the reason our international staff works with the uncommon illness neighborhood to establish, develop and ship life-changing therapies. In pursuit of this mission, we constantly search to grasp the varied views of uncommon sufferers and to courageously forge new paths to make a distinction of their lives and present hope – as we speak and tomorrow. For extra data, go to travere.com
Forward Looking Statements
This press launch comprises “forward-looking statements” as that time period is outlined within the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are sometimes recognized by the phrases “may”, “might”, “believes”, “thinks”, “anticipates”, “plans”, “expects”, “intends” or related expressions. In addition, expressions of our methods, intentions or plans are additionally forward-looking statements. Such forward-looking statements are primarily based on present expectations and contain inherent dangers and uncertainties, together with elements that would delay, divert or change any of them, and might trigger precise outcomes and outcomes to vary materially from present expectations. No forward-looking assertion may be assured. Such forward-looking statements embrace, however will not be restricted to, references to the efficacy, security and tolerability profile of sparsentan primarily based on the preliminary information from the DUPLEX and PROTECT Studies’ interim analyses and the potential for sparsentan to be the primary medication authorized for each FSGS and IgAN, if authorized for each indications. Such forward-looking statements are primarily based on present expectations and contain inherent dangers and uncertainties, together with elements that would delay, divert or change any of them, and might trigger precise outcomes and outcomes to vary materially from present expectations. No forward-looking assertion may be assured. Among the elements that would trigger precise outcomes to vary materially from these indicated within the forward-looking statements are dangers and uncertainties related to the regulatory assessment and approval course of, together with the Subpart H accelerated approval pathway within the United States and the conditional advertising authorization (CMA) pathway within the European Union, in addition to dangers and uncertainties related to the Company’s business and funds typically. Specifically, the Company faces the chance that the Phase 3 scientific trial of sparsentan in IgAN won’t show that sparsentan is protected or efficient or function a foundation for accelerated approval of sparsentan as deliberate; threat that the Phase 3 scientific trial of sparsentan in FSGS won’t show that sparsentan is protected or efficient or function the premise for conventional approval of sparsentan as deliberate; and threat that sparsentan won’t be authorized for efficacy, security, regulatory or different causes, and for every of the packages, threat related to enrollment of scientific trials for uncommon illnesses and threat that ongoing or deliberate scientific trials might not succeed or could also be delayed for security, regulatory or different causes. Also, there isn’t any assure that the non-clinical information which might be summarized within the abstracts which might be a topic of this press launch will translate to a viable therapeutic strategy in sufferers. The Company faces threat that it will likely be unable to lift further funding which may be required to finish improvement of all or any of its product candidates; threat referring to the Company’s dependence on contractors for scientific drug provide and industrial manufacturing; uncertainties referring to patent safety and exclusivity durations and mental property rights of third events; dangers related to regulatory interactions; dangers and uncertainties referring to aggressive merchandise, together with present and potential future generic competitors with sure of the Company’s merchandise, and technological modifications that will restrict demand for the Company’s merchandise. You are cautioned to not place undue reliance on these forward-looking statements as there are necessary elements that would trigger precise outcomes to vary materially from these in forward-looking statements, lots of that are past our management. The Company undertakes no obligation to publicly replace any forward-looking assertion, whether or not on account of new data, future occasions, or in any other case. Investors are referred to the complete dialogue of dangers and uncertainties as included within the Company’s most up-to-date Form 10-Ok, Form 10-Q and different filings with the Securities and Exchange Commission.
Contact:
| Investors: Investor Relations 888-969-7879 [email protected] |
Media: Nivi Nehra Vice President, Corporate Communications 888-969-7879 [email protected] |
