Travere Therapeutics, Inc. · NASDAQ:TVTX
Travere Therapeutics — Technical Presentation (June 2024)
26 slides from Travere Therapeutics's technical presentation, June 2024
Slide 1: Matching-Adjusted Indirect Comparisons of eGFR slopes in the PROTECT study
Matching-Adjusted Indirect Comparisons of eGFR slopes in the PROTECT study with UK RaDaR IgA Nephropathy population and the control arm of NefIgArd Dr Chee Kay Cheung Consultant Nephrologist and Honorary Associate Professor John Walls Renal Unit, Leicester General Hospital MA-SP-24-0061 06/2024
Slide 2: Disclosures
Disclosures • Consulting fees from George Clinical and Vera Therapeutics; honoraria from Stada; research funding from GSK and Travere Therapeutics, Inc.; advisory boards for Calliditas, CSL Vifor, and Novartis; steering committee/DSMC for CSL Vifor, Alpine Immune Sciences, and Roche; and travel supp
Slide 3: Learning Objectives
Learning Objectives At the conclusion of this CE* activity, participants should be better able to discuss PROTECT clinical trial results relative to delivery of standard of care (SoC) treatment for IgAN in other clinical settings. *This oral presentation was not originally submitted as a CE activity
Slide 4: Agenda
• Background • Study Objective Agenda • Methods • Results • Discussions & Conclusions 4 MA-SP-24-0061 06/2024
Slide 5: Background
Background Study Objective Methods Results Discussions & Conclusions 1 MA-SP-24-0061 06/2024
Slide 6: Immunoglobulin A nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) IgAN is an immune complex-mediated glomerulonephritis caused by the deposition of IgA in the glomerular mesangium and is often accompanied by persistent proteinuria, hypertension, and decreased kidney function1,2 Health resource use and costs rise Kidney failure i
Slide 7: PROTECT
PROTECT • PROTECT (NCT03762850) is a randomized, multicenter, double-blind, phase III trial comparing sparsentan (a dual endothelin and angiotensin receptor antagonist) against angiotensin receptor blocker (ARB), irbesartan, for the treatment of IgAN6 SPAR No study Open-label extension Double-blind
Slide 8: PROTECT
PROTECT SPAR No study Open-label extension Double-blind treatment period IRB medication period 110 Weeks 4 Weeks 156 Weeks Randomization 200 mg SPAR 400 mg SPAR Resume SoC 200/400 mg SPAR (N=202) Screening Discontinue ACEi/ARB 150 mg IRB 300 mg IRB Resume SoC 200/400 mg SPAR (N=202) N=404 End of Key
Slide 9: Study Objective
Background Study Objective Methods Results Discussions & Conclusions 2 MA-SP-24-0061 06/2024
Slide 10: Study objective
Study objective • This study aimed to assess the effect of treatment with sparsentan and irbesartan versus (vs) SoC on the two- year eGFR total slope, which represents the annual rate of decline in eGFR over two years • In the absence of head-to-head randomized trials, this assessment was conducted
Slide 11: Methods
Background Study Objective Methods Results Discussions & Conclusions 3 MA-SP-24-0061 06/2024
Slide 12: Data sources and comparisons
Data sources and comparisons • Two published data sources for patients with IgAN who received SoC were utilized to compare sparsentan and irbesartan against SoC, respectively • The UK National Registry of Rare Kidney Diseases (RaDaR), reflecting SoC in the real-world setting5 • The control arm from
Slide 13: Published Data source (RaDaR)
Published Data source (RaDaR) • RaDaR, an initiative designed by the UK Kidney Association, amalgamates data on patients with select rare kidney diseases, including IgAN5 • It has enrolled patients from 106 adult and pediatric kidney units across the UK5 • Patients enrolled in RaDaR received SoC tre
Slide 14: Published Data source (NefIgArd)
Published Data source (NefIgArd) • NefIgArd (NCT03643965) is a randomized, multicenter, double-blind phase III trial of targeted-release formulation (TRF) budesonide versus (vs) placebo with background optimized and stable renin-angiotensin system (RAS) inhibitor therapy (RAS SoC) for the treatment
Slide 15: Review of SoC
Review of Real-World Population • Assumed to be RASi, blood pressure control, and lifestyle management5 SoC (RaDaR) • Stable and optimized RASi therapy with ACEi and/or ARB for at least 3 months before screening ▪ Interim Safety Analysis Set (n=144)8 ▪ Use of RASi in 97% (n=140/144) of patients with
Slide 16: Comparative method – unanchored MAIC
Comparative method – unanchored MAIC • MAIC is an indirect treatment comparison method to compare the effectiveness of two treatments when individual patient-level data are available for one treatment while only aggregate data are available for the other treatment7 • Specifically, in our study, pati
Slide 17: Results
Background Study Objective Methods Results Discussions & Conclusions 4 MA-SP-24-0061 06/2024
Slide 18: Sparsentan and irbesartan vs. RaDaR SoC
Sparsentan and irbesartan vs. RaDaR SoC • Compared with patients in RaDaR, those in PROTECT exhibited older age, a lower proportion of White patients, a higher proportion of Asian patients, lower systolic blood pressure, lower eGFR, lower urine protein-creatinine ratio (UP/C), and a longer duration
Slide 19: Sparsentan and irbesartan vs. RaDaR SoC (cont'd)
Sparsentan and irbesartan vs. RaDaR SoC (cont’d) • After matching, patients treated with maximally titrated irbesartan or sparsentan in the PROTECT trial exhibit a slower decline in kidney function compared to SoC delivered in a real-world setting (RaDaR), with a difference of 1.12 ml/min/1.73m2 per
Slide 20: Sparsentan and irbesartan vs. NefIgArd SoC
Sparsentan and irbesartan vs. NefIgArd SoC • Compared with patients in the NefIgArd trial, those in the PROTECT trial exhibited older age, higher blood pressures, lower eGFR levels, lower urine protein levels, a higher proportion of baseline diabetes, and a longer duration since biopsy • After weigh
Slide 21: Sparsentan and irbesartan vs. NefIgArd SoC (cont'd)
Sparsentan and irbesartan vs. NefIgArd SoC (cont’d) • Similar results were observed compared to SoC delivered in the clinical trial setting (NefIgArd), with a difference of 1.30 ml/min/1.73m2 per year (p=0.0395) for irbesartan and 2.26 ml/min/1.73m2 per year (p=0.0004) for the sparsentan, respective
Slide 22: Discussions & Conclusions
Background Study Objective Methods Results Discussions & Conclusions 5 MA-SP-24-0061 06/2024
Slide 23: Discussions and Conclusions
Discussions • In the absence of head-to-head trials comparing sparsentan vs SoC, MAIC is an appropriate approach that can be utilized to generate relevant comparative evidence using sufficiently aligned data sources • Results from this study provide important context for the performance of treatment
Slide 24: References
References 1. Wyatt RJ, Julian BA. IgA nephropathy. New England Journal of Medicine. 2013 Jun 20;368(25):2402-14. 2. Rovin BH, Adler SG, Barratt J, Bridoux F, Burdge KA, Chan TM, Cook HT, Fervenza FC, Gibson KL, Glassock RJ, Jayne DR. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Dise
Slide 25: Questions
Questions 21-Aug-24 25 MA-SP-24-0061 06/2024
Slide 26: MA-SP-24-0061
MA-SP-24-0061 06/2024
Travere Therapeutics — Technical Presentation (June 2024) on 6ix