Travere Therapeutics, Inc. · NASDAQ:TVTX
Travere Therapeutics — Technical Presentation (June 2025)
16 slides from Travere Therapeutics's technical presentation, June 2025
Slide 1: Patients With FSGS Achieved Low Proteinuria Targets Earlier and More Often With Sparsentan vs Irbesartan in DUPLEX
Patients With Focal Segmental Glomerulosclerosis (FSGS) Achieved Low Proteinuria Targets Earlier and More Often With Sparsentan (SPAR) vs Irbesartan (IRB) in DUPLEX V TESAR,1 H TRIMARCHI,2 J TUMLIN,3 L KOOIENGA,4 R KOMERS,5 J INRIG,5 E MURPHY,5 E RODRÍGUEZ6 1General University Hospital in Prague, Pr
Slide 2: Introduction
INTRODUCTION • FSGS is associated with a substantial risk of kidney failure, with 40% to 60% of patients progressing to kidney failure or death within 10 to 20 years of diagnosis1,2 • There are no approved pharmacologic therapies for FSGS, highlighting an unmet need for safe and effective treatments
Slide 3: Methods: DUPLEX Study Design
METHODS • DUPLEX (NCT03493685) is a phase 3, randomized, double-blind trial investigating the safety and efficacy of SPAR vs active control, maximum labeled dose IRB, in adult and pediatric patients (aged ≥8 years) with FSGS DUPLEX Study Design 4 weeks post cessation Washout period Double-blind trea
Slide 4: Methods: Study Endpoints
METHODS • Study endpoints were defined as follows: 1. CR of proteinuria: UPCR of <0.3 g/g 2. FSGS partial remission endpoint: urine protein-to-creatinine ratio (UPCR) of ≤1.5 g/g and a >40% reduction from baseline8 3. Kidney failure: eGFR of <15 mL/min/1.73 m2 or kidney replacement therapy • Analyse
Slide 5: Patient Demographics and Baseline Characteristics
RESULTS Patient Demographics and Baseline Characteristics • A total of 371 patients were randomized to receive SPAR or IRB in DUPLEX SPAR IRB All patients n=184 n=187 N=371 Age, mean (SD), years 41.7 (16.5) 41.5 (17.3) 41.6 (16.9) <18 years, n (%) 16 (8.7) 19 (10.2) 35 (9.4) Male sex, n (%) 101 (55)
Slide 6: SPAR Demonstrated Superior and Consistent Proteinuria Reduction Across Thresholds
RESULTS SPAR Demonstrated Superior and Consistent Proteinuria Reduction Across Thresholds vs Maximum Labeled Dose IRB RR, 1.36 (95% CI, 1.16-1.59) RR, 1.48 80 any time through 108 weeks, % SPAR (95% CI, 1.23-1.78) Patients reaching threshold at RR, 1.49 69.0 70 64.7 IRB (95% CI, 1.19-1.86) 60 53.3 5
Slide 7: Patients Achieved CR of Proteinuria
RESULTS Patients Achieved CR of Proteinuria* Earlier and More Often With SPAR vs Maximum Labeled Dose IRB RR, 2.47 (95% CI, 1.37-4.45) SPAR Patients reaching threshold at any 20 18.5 0.20 time through 108 weeks, % Median time to CR of proteinuria SPAR (NE in either group; difference, P=.0008†) IRB P
Slide 8: Patients Achieved UPCR of <0.5 g/g
RESULTS Patients Achieved UPCR of <0.5 g/g Earlier and More Often With SPAR vs Maximum Labeled Dose IRB RR, 2.15 (95% CI, 1.44-3.20) 0.40 Patients reaching threshold at any SPAR Median time to UPCR <0.5 g/g 35 time through 108 weeks, % (NE in either group; difference, P=.0001*) 31.0 SPAR Probability
Slide 9: Patients Achieved UPCR of <1.0 g/g
RESULTS Patients Achieved UPCR of <1.0 g/g Earlier and More Often With SPAR vs Maximum Labeled Dose IRB Median time to UPCR <1.0 g/g (Difference, P<.0001*) RR, 1.49 0.60 SPAR, 49.1 weeks (95% CI, 1.19-1.86) Patients reaching threshold at any 60 time through 108 weeks, % 53.3 SPAR Probability of achi
Slide 10: Patients Achieved UPCR of <1.5 g/g
RESULTS Patients Achieved UPCR of <1.5 g/g Earlier and More Often With SPAR vs Maximum Labeled Dose IRB RR, 1.36 Median time to UPCR <1.5 g/g (Difference, P<.0001*) (95% CI, 1.16-1.59) 0.80 SPAR, 12.7 weeks IRB, 55.6 weeks Patients reaching threshold at any 70 69.0 time through 108 weeks, % SPAR Pro
Slide 11: Patients Achieved the FSGS Partial Remission Endpoint
RESULTS Patients Achieved the FSGS Partial Remission Endpoint* Earlier and More Often With SPAR vs Maximum Labeled Dose IRB RR, 1.48 Median time to FSGS partial remission (95% CI, 1.23-1.78) endpoint (Difference, P<.0001†) Patients reaching threshold at any IRB, 109.0 weeks FSGS partial remission en
Slide 12: Patients Achieving Remission Less Likely to Develop Kidney Failure
RESULTS Irrespective of Treatment, Patients Who Achieved the FSGS Partial Remission Endpoint or CR of Proteinuria Were Less Likely To Develop Kidney Failure vs Those Who Did Not* RR, 0.33 through 108 weeks (95% CI), % (95% CI, 0.11-0.95) Patients reaching kidney failure 30 RR, 0.23 15.9% 25 (95% CI,
Slide 13: SPAR Was Well Tolerated, Safety Profile Comparable to IRB
RESULTS SPAR Was Well Tolerated, With a Safety Profile Comparable To That of IRB • The most common TEAEs (≥15% in either group) included COVID-19, hyperkalemia, peripheral edema, and hypotension SPAR IRB All patients Patients with TEAEs, n (%) n=184 n=187 N=371 Any TEAEs 172 (93) 174 (93) 346 (93) S
Slide 14: Conclusions
CONCLUSIONS • Dual endothelin angiotensin receptor blockade with SPAR led to clinically meaningful low proteinuria thresholds, including CR of proteinuria or the FSGS partial remission endpoint, being achieved earlier and more often in patients with FSGS than did angiotensin receptor blockade alone
Slide 15: References
REFERENCES 1. Cravedi P, et al. Am J Transplant. 2013;13(2):266-274. 2. Pitcher D, et al. ERA 2024. Oral presentation 901. 3. Gipson DS, et al. JAMA Netw Open. 2022;5(8):e2228701. 4. Smith AR, et al. ASN 2024. Abstract INFO10-SA. 5. Kohan DE, et al. Clin Sci. 2024;138(11):645-662. 6. Trachtman H, et
Slide 16: Disclosures
DISCLOSURES • VT reports reports consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Calliditas Therapeutics, GSK, Eli Lilly, Novartis, Otsuka Pharmaceuticals, Travere Therapeutics, Inc., and Vera Therapeutics; honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Calliditas Therapeuti
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