Press Release
Akebia Announces Publication of Phase 2a Results for Vadadustat in Patients with Anemia Related to Chronic Kidney Disease
-- Data Showed Vadadustat Increased Hemoglobin Levels and Improved Iron Mobilization When Compared to Placebo --
This multicenter, six-week, randomized, double-blind, placebo-controlled, dose-ranging Phase 2a trial evaluated the pharmacodynamic response, safety and tolerability of once-daily oral dose of vadadustat in non-dialysis patients with anemia related to CKD Stage 3 or 4. Ninety-three patients were randomized to one of five dose groups: 240, 370, 500, or 630 mg of once daily oral vadadustat or matching placebo for six weeks of treatment.
Findings from the study included:
- Vadadustat increased hemoglobin levels in patients across all treatment groups compared to placebo;
- Vadadustat improved iron mobilization compared to the placebo group, as measured by decreases in ferritin and hepcidin and increases in total iron binding capacity; and
- Safety findings were consistent with results of other studies of vadadustat and the proportion of patients with at least one treatment-emergent adverse event was similar between the vadadustat and placebo-treated groups, with no apparent dose-related effect.
"This Phase 2a publication further demonstrates the potential of
vadadustat to set a new standard of care in renal anemia and provides a
strong basis for our global Phase 3 program, which continues to enroll
CKD patients in both the non-dialysis and dialysis dependent setting,"
said
About Vadadustat
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.
About Anemia Associated with CKD
Approximately 30 million people in the
About
Forward-Looking Statements
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 and benefits of vadadustat. 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
funding required to develop vadadustat and operate the company, and the
actual expenses associated therewith; the actual costs incurred in the
Phase 3 studies of vadadustat and the availability of financing to cover
such costs; the timing and content of decisions made by the
View source version on businesswire.com: http://www.businesswire.com/news/home/20170328005120/en/
SVP,
Corporate Communications
and Investor Relations
tmcneely@akebia.com
Source:
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Akebia Therapeutics, Inc.
245 First Street, Suite 1400
Cambridge, MA 02142
+1 617.871.2098 phone
+1 617.871.2099 fax