Akebia Therapeutics Announces Positive Top-Line Results from Phase 2 Study of Vadadustat in Japanese Patients with Anemia Associated with Dialysis-Dependent Chronic Kidney Disease
-- Data Consistent with Findings from Previous Studies --
-- Phase 3 Study of Non-Dialysis Patients in
“These positive top-line Phase 2 results in dialysis-dependent patients
The double-blind, placebo-controlled, dose-finding Phase 2 study was designed to evaluate the efficacy, safety and tolerability of orally-administered vadadustat in Japanese patients with anemia associated with DD-CKD. This 16-week study evaluated 60 patients during a 6-week placebo-controlled, fixed-dose period and a 10-week active treatment, dose adjustment and maintenance period.
The primary efficacy endpoint was mean hemoglobin change from baseline to week 6 comparing vadadustat to placebo. Statistically significant improvements in the primary endpoint were observed in the vadadustat groups, 150 mg (p = 0.0004), 300 mg (p < 0.0001), and 600 mg (p < 0.0001), compared to placebo. The data indicate a dose-response for vadadustat.
The incidence of adverse events during the 6-week placebo-controlled, fixed-dose period in the vadadustat groups (150 mg, 300 mg and 600 mg) and placebo was 53%, 73%, 40%, and 40%, respectively. During the 16-week study and the 2-week follow-up period, the most common adverse events reported were nasopharyngitis (20%), diarrhea (13.3%), and headache (10%). Serious adverse events were consistent with prior studies and included 10 SAEs in 7 patients, none of which were considered drug related. No deaths were reported.
Akebia and MTPC plan to present the data from the NDD-CKD and DD-CKD
Phase 2 studies conducted in
Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia related to chronic kidney disease. Vadadustat exploits the same mechanism of action used by the body to adapt naturally to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery.
Statements in this press release regarding Akebia’s strategy, plans, prospects, expectations, beliefs, intentions or goals are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including but not limited to statements regarding the timing of clinical trials; the timing, availability and presentation of clinical trial data and results; the potential commercialization of vadadustat in
Akebia Therapeutics Contact:
John Garabo, 617-844-6130
Director, Corporate Communications