Kidney Effects in the MOXIe Trial: Presentation at ERA-EDTA 2020

In Part 2 of the Phase 2 MOXIe study of omaveloxolone in patients with Friedreich’s ataxia, a rapid, continuous decline in kidney function as measured by eGFR was observed in the placebo group. Omaveloxolone treatment for 48 weeks was associated with an increase in eGFR. These increases were durable and sustained throughout one year of treatment, similar to results observed with its analog, bardoxolone methyl, in clinical trials for various forms of CKD.

  • The rate of eGFR decline in patients with FA was equal to or greater than many forms of CKD.
  • Rapidly progressive loss of kidney function in patients without traditional risk factors for CKD highlight the role of mitochondrial dysfunction in progression of CKD.
  • Placebo-corrected increases in patients treated with omaveloxolone were durable through one year of treatment.

Data Presentation: Positive Topline Pivotal MOXIe Data

Reata announced that the registrational Part 2 portion of the MOXIe Phase 2 trial of omaveloxolone in patients with Friedreich’s ataxia met its primary endpoint of change in the modified Friedreich’s Ataxia Rating Scale (mFARS) relative to placebo after 48 weeks of treatment.

  • Part 2 of MOXIe, an international, multi-center, double-blind, placebo-controlled, randomized registrational Phase 2 trial, enrolled 103 patients with FA.
  • Omaveloxolone treatment met the primary endpoint of the study producing a statistically significant, placebo-corrected 2.40 point improvement (decrease) in mFARS (n=82; p=0.014).
  • Omaveloxolone was generally reported to be well tolerated in this study.