-- Data Showed Vadadustat Increased Hemoglobin Levels and Improved
Iron Mobilization When Compared to Placebo --
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company
focused on delivering innovative therapies to patients with kidney
disease through the biology of hypoxia-inducible factor (HIF), today
announced the publication of positive results from a Phase 2a study of
vadadustat, a once-daily oral HIF stabilizer in development for the
treatment of anemia related to chronic kidney disease (CKD). The study
demonstrated that vadadustat increased hemoglobin levels in a
dose-dependent manner and improved iron mobilization in non-dialysis CKD
patients when compared to placebo. The peer-reviewed paper, titled
"Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage
3 or 4 Chronic Kidney Disease," was published online by the American
Journal of Nephrology. Vadadustat is currently being evaluated
in a global Phase 3 clinical program in non-dialysis and dialysis
patients with anemia related to CKD.
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 Brad Maroni, M.D., Chief Medical Officer at Akebia.
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 U.S. have chronic kidney disease
(CKD), with an estimated 1.8 million of these patients suffering from
anemia. Anemia results from the body's inability to coordinate red blood
cell production in response to lower oxygen levels due to the
progressive loss of kidney function with inadequate erythropoietin
production. Left untreated, anemia significantly accelerates patients'
overall deterioration of health with increased morbidity and mortality.
Anemia is currently treated with injectable recombinant erythropoiesis
stimulating agents, which are associated with inconsistent hemoglobin
responses and well-documented safety risks.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered
in Cambridge, Massachusetts, focused on delivering innovative therapies
to patients with kidney disease through hypoxia-inducible factor
biology. Akebia's lead product candidate, vadadustat, is an
investigational oral therapy in development for the treatment of anemia
related to chronic kidney disease in both non-dialysis and dialysis
patients. Akebia's global Phase 3 program for vadadustat, which includes
the PRO2TECT studies for non-dialysis patients with anemia
secondary to chronic kidney disease and the INNO2VATE studies
for dialysis-dependent patients, is currently ongoing. For more
information, please visit our website at www.akebia.com.
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 FDA and
other regulatory authorities; the actual time it takes to initiate and
complete research and development; 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 and its other product candidates. Other risks and
uncertainties include those identified under the heading "Risk Factors"
in Akebia's Annual Report on Form 10-K for the year ended December 31,
2016, and other filings that Akebia may make with the Securities and
Exchange Commission in the future. Akebia does not undertake, and
specifically disclaims, any obligation to update any forward-looking
statements contained in this press release.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170328005120/en/
Akebia Therapeutics, Inc.
Theresa McNeely, 617-844-6113
and Investor Relations
Source: Akebia Therapeutics, Inc.
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