Heart Protection Study

Travere Therapeutics Announces Late-Breaking Data from Phase 3 Studies of Sparsentan in IgAN and FSGS Published in The Lancet and The NEJM Respectively and Presented at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Friday, November 3, 2023

SAN DIEGO, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced additional data from two pivotal clinical studies demonstrating sparsentan has the potential to preserve kidney function and significantly delay time to kidney failure compared to an active comparator, suggesting long-term benefits in IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS). Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet (PROTECT) and The New England Journal of Medicine (DUPLEX).

Key Points: 
  • Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet (PROTECT ) and The New England Journal of Medicine (DUPLEX) .
  • The absolute overall change in kidney function from baseline to the end of the study for patients treated with FILSPARI was -5.8 mL/min/1.73m2 compared to -9.5 mL/min/1.73m2 with irbesartan.
  • Treatment with FILSPARI demonstrated lower rates of the composite endpoint of 40% decline in eGFR, kidney failure or death compared to irbesartan.
  • Sparsentan showed a consistent and sustained achievement of complete remission of proteinuria in 18.5% of patients on sparsentan vs. 7.5% for irbesartan.

BARDA Expands Partnership With Evidation to Validate and Improve Machine Learning Models for Early Detection of Influenza-like Illness Using Wearables

Retrieved on: 
Tuesday, October 17, 2023

The Detect & Protect Studies will support the development of machine learning models to detect respiratory viral infections with data collected from consumer-grade wearable devices.

Key Points: 
  • The Detect & Protect Studies will support the development of machine learning models to detect respiratory viral infections with data collected from consumer-grade wearable devices.
  • This contract will also fund research to expand and better understand the potential impact of Evidation’s FluSmart program to encourage protective health behaviors.
  • This is the third BARDA award issued to Evidation to advance understanding and detection tools for respiratory infections.
  • In 2020, BARDA funded follow-on research to investigate if and how machine learning models and novel data from wearables could be used to detect symptoms of COVID-19 infection .

Travere Therapeutics to Present Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Friday, October 13, 2023

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.

Key Points: 
  • 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.

Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control, Irbesartan

Retrieved on: 
Thursday, September 21, 2023

This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.

Key Points: 
  • This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.
  • “Since our accelerated approval, we’ve continued to hear inspiring stories of the impact this medicine is having on people living with IgAN.
  • While eGFR total slope narrowly missed statistical significance, the overall evidence from PROTECT suggests potential long-term benefit of FILSPARI as a foundational treatment for patients with IgAN.
  • Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website.

Ligand’s Partner Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control

Retrieved on: 
Thursday, September 21, 2023

This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.

Key Points: 
  • This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.
  • We’re proud of the high bar we’ve set in delivering the only head-to-head study in IgAN, which compares FILSPARI against maximally tolerated dose of irbesartan.
  • Since our accelerated approval, we’ve continued to hear inspiring stories of the impact this medicine is having on people living with IgAN.
  • While eGFR total slope narrowly missed statistical significance, the overall evidence from PROTECT suggest potential long-term benefit of FILSPARI as a foundational treatment for patients with IgAN.

Travere Therapeutics Announces Presentations of Abstracts at the 60th European Renal Association (ERA) Congress 2023

Retrieved on: 
Thursday, June 8, 2023

SAN DIEGO, June 08, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company and its collaborators will present nine abstracts, including the interim analysis from the ongoing Phase 3 PROTECT Study evaluating FILSPARI™ (sparsentan) versus an active comparator in IgA nephropathy (IgAN), at the 60th ERA Congress in Milan, Italy, June 15-18, 2023.

Key Points: 
  • SAN DIEGO, June 08, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company and its collaborators will present nine abstracts, including the interim analysis from the ongoing Phase 3 PROTECT Study evaluating FILSPARI™ (sparsentan) versus an active comparator in IgA nephropathy (IgAN), at the 60th ERA Congress in Milan, Italy, June 15-18, 2023.
  • Also included in the presentations is a new analysis of the UK RaDaR Registry estimating the delay in time to kidney failure or death based on proteinuria reduction in IgAN, which has been designated among the 10 best-ranked abstracts of 2023 by ERA.
  • “We’re pleased to bring to the ERA Congress the strong interim results from our ongoing PROTECT Study which demonstrate that sparsentan significantly reduces proteinuria in IgA nephropathy,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.
  • “We also look forward to sharing more data from the IgA nephropathy field showing the relationship between reducing proteinuria in IgA nephropathy and preservation of kidney function.”
    Session: The Art of Staring at Urine: Studies in IgA Nephropathy
    Session: The Art of Staring at Urine: Studies in IgA Nephropathy
    Alport Syndrome Natural History from the RaDaR Registry: Associations with Gene, Variant Type and Sex
    Humanistic Burden of Rare Kidney Diseases: Understanding the Impact of IgAN and FSGS on Patients & Care-Partners Study (HONUS): US IgAN Results Update

Travere Therapeutics Reports First Quarter 2023 Financial Results

Retrieved on: 
Thursday, May 4, 2023

SAN DIEGO, May 04, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its first quarter 2023 financial results and provided a corporate update.

Key Points: 
  • FILSPARI™(sparsentan) granted accelerated approval by FDA for the reduction of proteinuria in IgA nephropathy (IgAN) on February 17th, 2023; commercial launch underway
    Total net product sales of $50.3 million for the first quarter of 2023, including $3.0 million for FILSPARI
    SAN DIEGO, May 04, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its first quarter 2023 financial results and provided a corporate update.
  • Travere Therapeutics will host a conference call and webcast today, Thursday, May 4, 2023, at 4:30 p.m.
  • ET to discuss company updates as well as first quarter 2023 financial results.
  • The Company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results.

Interim Analysis of the Phase 3 PROTECT Study of FILSPARI™ (Sparsentan) in IgA Nephropathy Presented by Travere Therapeutics at NKF Spring Clinical Meetings

Retrieved on: 
Thursday, April 13, 2023

Data demonstrates a significant and clinically meaningful anti-proteinuric effect of Sparsentan compared to Irbesartan.

Key Points: 
  • Data demonstrates a significant and clinically meaningful anti-proteinuric effect of Sparsentan compared to Irbesartan.
  • "The data also highlight a consistent treatment effect across patient populations, regardless of age, race, gender, clinical characteristics, and concomitant medications."
  • Data from the study were recently published in The Lancet and announced by Travere Therapeutics.
  • Thousands of kidney care professionals will attend the Spring Clinical Meetings in-person and virtually.

Travere Therapeutics Announces Interim Analysis from the Phase 3 PROTECT Study of FILSPARI™ (Sparsentan) in IgA Nephropathy Published in The Lancet and Presented at World Congress of Nephrology 2023

Retrieved on: 
Saturday, April 1, 2023

The data are simultaneously being presented in a late-breaking trials session at the World Congress of Nephrology 2023, in Bangkok, Thailand.

Key Points: 
  • The data are simultaneously being presented in a late-breaking trials session at the World Congress of Nephrology 2023, in Bangkok, Thailand.
  • 70.3% of participants in the FILSPARI group achieved partial remission, compared to 44.1% of participants in the irbesartan group (p
  • No cases of severe edema, heart failure, hepatotoxicity, or edema-related discontinuations were reported in the study as of the cutoff date.
  • The analysis published in The Lancet includes available efficacy data through the cutoff date of August 1, 2021, and available safety data through the cutoff date of February 1, 2022.

Travere Therapeutics Announces Late-Breaker Presentations of the Interim Analysis from the Phase 3 PROTECT Study of FILSPARI™ (Sparsentan) in IgA Nephropathy at the ISN World Congress of Nephrology and NKF Spring Clinical Meetings 2023

Retrieved on: 
Thursday, March 23, 2023

FILSPARI (sparsentan), a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), recently received U.S. accelerated approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a UPCR ≥1.5 g/g.

Key Points: 
  • FILSPARI (sparsentan), a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), recently received U.S. accelerated approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a UPCR ≥1.5 g/g.
  • FILSPARI (sparsentan) is continuing to advance to the two-year confirmatory endpoints in the ongoing PROTECT Study and sparsentan is also in Phase 3 clinical development for the treatment of focal segmental glomerulosclerosis (FSGS).
  • The Company and its collaborators will also present baseline characteristics across patient populations participating in the PROTECT Study, as well as long-term clinical data from the ongoing open-label extension of the Phase 2 DUET Study of sparsentan in FSGS.
  • World Congress of Nephrology, Bangkok, Thailand – March 30-April 2, 2023
    Long-term Efficacy and Safety of Sparsentan in Young Patients with FSGS: 240-week Analysis of the DUET Open Label Extension
    Proteinuria and Its Association with Disease Progression in IgA Nephropathy: Analysis of the UK National RaDaR IgA Nephropathy Cohort