Akebia is a leader in the development of a small molecule that stabilizes HIF2a (HIF-PH inhibitor) designed to increase the natural production of erythropoietin (EPO) and cause a controlled, gradual rise in hemoglobin in patients with anemia.
AKB-6548: Target Profile
- Oral, once daily dosing
- Restores Hgb to a target level
- Restores and/or enhances diurnal EPO response
- Titratable therapy – EPO, Hgb, etc.
- Improves iron therapy – minimizes Hepcidin-related iron sequestration
- 400 – 600 mg dose
- Minimal side effects
- Favorable COGs with excellent shelf life
AKB-6548: New Information
- Completed 90 patient study in CKD 3 and 4 patients (full unblinded dataset available end of March)
- Effective therapy in the range of 300 to 600 mg daily
- Generally well tolerated up to 42 days of dosing in subjects with CKD, Stages 3, 4, and 5 (not on dialysis).
- Titratable therapy – i.e., rapid adjustment in red blood cell production with change in dose (can control rate of rise)
- Favorable response from FDA – Hgb cutoffs different from EPO and validated CV event rate meta-analysis for Phase 3 studies (i.e. total patient number required <2500)
- CMC ready to support Phase 3 development