01-04-2019 Update

Reata Announces Clinical Trial Design for FALCON, a Phase 3 Trial of Bardoxolone Methyl for the Treatment of ADPKD

Reata Management Call to Discuss Phase 3 ADPKD Study Design

 MP3

Overview

  • ADPKD is the leading, inheritable cause of kidney failure in the US, occurring in approximately 116,000 patients1
  • ADPKD is a genetic form of CKD caused by mutations in the PKD1 and PKD2 genes1-3
  • Genetic mutations cause the formation of fluid-filled cysts in the kidneys1-3
  • Cyst growth displaces normal kidney tissue, triggers an immune response leading to interstitial inflammation and fibrosis, and results in progressive loss of kidney function and eventual kidney failure1-3

PHOENIX Trial Overview

PHOENIX is an open-label, multicenter, phase 2 US trial designed to evaluate the safety, tolerability, and efficacy of bardoxolone methyl in four separate patient cohorts. The target enrollment is 25 to 30 patients per cohort.

PHOENIX Trial Details

  • Patient cohorts: ADPKD, IgAN, T1D CKD, and FSGS
    • Age: 18-65 years
    • eGFR: 30-90 mL/min/1.73 m2
  • Primary endpoint: change from baseline in eGFR at week 12
  • Treatment: bardoxolone methyl, orally, once-daily for 12 weeks

PHOENIX Trial Design

PHOENIX-Trial-Design

References
  1. National Human Genome Research Institute. Learning about autosomal dominant polycystic kidney disease. http://www.genome.gov/20019622/learning-about-autosomal-polycystic-kidney-disease. Accessed November 7, 2018.
  2. Chebib FT, Torres VE. Autosomal dominant polycystic kidney disease: Core curriculum 2016. Am J Kidney Dis. 2016;67(5):792-810.
  3. Li X, Magenheimer BS, Xia S, et al. A tumor necrosis factor-alpha-mediated pathway promoting autosomal dominant polycystic kidney disease. Nat Med. 2008;14(8):863-868.