Products Overview

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