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.