Akebia Announces Positive Top-Line Results from Phase 2 Study of Vadadustat in Japanese Patients with Non-Dialysis-Dependent Chronic Kidney Disease
- Data Confirms Findings from Previous Studies -
- Phase 3 Study in
- Akebia Provides Mitsubishi Tanabe with Option to Access Global Phase 3 Vadadustat Data for Payments of up to
"We are pleased that the Phase 2 Japan results in NDD-CKD patients are consistent with data from our prior studies and we anticipate that the upcoming results in dialysis patients will provide further confirmation of vadadustat's potential," said
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 NDD-CKD. This 16-week study evaluated 51 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, 150mg, (p < 0.0045), 300mg, (p < 0.0001), and 600mg (p < 0.0001), compared to placebo. The data indicate a dose-response for vadadustat.
The incidence of any adverse events during the 6-week placebo-controlled, fixed-dose period in the vadadustat groups (150mg, 300mg, and 600mg) and placebo was 33%, 58%, 54%, and 36%, respectively. During the 16-week study, the most common adverse events reported were viral upper respiratory tract infection (12%) and hypertension (10%). Serious adverse events were consistent with prior studies and included 13 in 11 patients. No deaths were reported.
Akebia expects to present the data at an upcoming scientific meeting and publish the study results in a peer-reviewed journal.
Following consultation with the
"The local Japanese development strategy provides a clear and potentially expedited path forward for vadadustat in this large and growing market," said
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.
This press release includes forward-looking statements. Such forward-looking statements include those about Akebia's strategy, future plans and prospects, including statements regarding the potential commercialization of vadadustat in
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