-Treatment with Vadadustat Successfully Maintained Mean Hemoglobin Levels Following Conversion from rESA Therapy-
-Vadadustat Demonstrated a Favorable Safety Profile with
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The open-label, multi-center, 94 patient study was designed to evaluate the ability of vadadustat to maintain hemoglobin levels in patients undergoing hemodialysis who were previously being treated with rESAs. Patients were assigned to one of three dose cohorts: once daily vadadustat at a starting dose of 300mg, once daily vadadustat at a starting dose of 450mg, or vadadustat three times per week in conjunction with the patient's hemodialysis schedule at a starting dose of 450mg. The study achieved its primary endpoints of maintaining stable hemoglobin levels over 16 weeks of treatment in all three cohorts of patients converting from rESAs to vadadustat.
|Mean Hemoglobin Levels (g/dL)*||Baseline||Week 7/8||Week 15/16|
|300mg Daily Dose||10.4||10.4||10.3|
|450mg Daily Dose||10.6||10.3||10.5|
|450mg Three Times per Week Dose||10.5||10.2||10.4|
* Modified intent-to-treat (MITT) population, n=94
Vadadustat was well tolerated among patients in all three dose cohorts. Treatment-emergent adverse events (TEAEs) with vadadustat were balanced across the cohorts. Serious adverse events (SAEs) were reported in 13 subjects (13.8%), well within the expected range for this patient population. There were no drug-related SAEs and no deaths reported in the study.
"This study was a clear success, demonstrating the potential of
vadadustat to effectively and safely treat anemia in dialysis patients
switching from injectable rESA therapy," said
Complete efficacy and safety data from this Phase 2 study will be presented at an upcoming medical meeting.
About the Phase 2 Study Design of Vadadustat in Dialysis Patients with Anemia Related to CKD
The Phase 2 multi-center, open-label study evaluated 94 patients over 16
weeks of treatment, at 20 dialysis centers in
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About Vadadustat (Formerly AKB-6548)
Vadadustat is an oral therapy currently in development for the treatment of anemia related to CKD. Vadadustat is designed to stabilize HIF, a transcription factor that regulates the expression of genes involved with red blood cell (RBC) production in response to changes in oxygen levels, by inhibiting the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzyme. Vadadustat exploits the same mechanism of action used by the body to naturally adapt 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 (EPO) production to increase RBC production and, ultimately, improve oxygen delivery.
As a HIF stabilizer with best-in-class potential, vadadustat raises hemoglobin levels predictably and sustainably, with a dosing regimen that allows for a gradual and controlled titration. Vadadustat has been shown to improve iron mobilization, potentially eliminating the need for intravenous iron administration and reducing the overall need for iron supplementation.
About Anemia Related to CKD
Approximately 30 million people in
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
indications, dosing and benefits of vadadustat, the development plan for
vadadustat, plans for presenting a more detailed analysis of the data
from the Phase 2 study, and the initiation of the Phase 3 program. The
words "anticipate," "appear," "believe," "estimate," "expect," "intend,"
"may," "plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Each
forward-looking statement is subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or
implied in such statement, including the risk that existing preclinical
and clinical data may not be predictive of the results of ongoing or
later clinical trials; the ability of Akebia to successfully complete
the clinical development of vadadustat; the funding required to develop
Akebia's product candidates and operate the company, and the actual
expenses associated therewith; the cost of our Phase 3 studies and the
availability of financing to cover such cost; the timing and content of
decisions made by the FDA and other regulatory authorities; the
acceptance of Akebia's abstract for presentation at a medical meeting;
the actual time it takes to prepare for and initiate Phase 3 clinical
studies; the success of competitors in developing product candidates for
diseases for which Akebia is currently developing its product
candidates; and Akebia's ability to obtain, maintain and enforce patent
and other intellectual property protection for vadadustat. Other risks
and uncertainties include those identified under the heading "Risk
Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended
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