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.
Reata and Invitae are sponsoring KIDNEYCODE, a no-charge genetic testing program, to help nephrologists identify patients with genetic forms of CKD.
- Seventy-eight percent of patients with eGFR below normal, a family history of CKD, and hematuria have been found to have Alport syndrome in the KidneyCode program including variants of uncertain significance in COL4A3, COL4A4, and COL4A5 genes.
- Of the tests that have results that we can access, approximately half have been positive for Alport syndrome, and half of these patients were previously misdiagnosed with other forms of CKD including variants of uncertain significance in COL4A3, COL4A4, and COL4A5 genes.