Akebia Announces Publication Highlighting Potential Benefits of HIF Treatments for Patients with Renal Anemia
September 26 2016 - 7:00AM
Business Wire
-- Study Confirms Association Between Higher
Altitude and Favorable Changes in Dialysis Patients --
Akebia 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 a study which concluded
that higher altitude is associated with higher hemoglobin levels
and lower mortality, despite lower utilization of
erythropoiesis-stimulating agent (ESA) and intravenous iron.
Treatments that mimic the effect of higher altitude, such as HIF
therapies, may provide beneficial effects for renal anemia
patients, including improved iron mobilization and erythropoietin
synthesis. The article, titled “The Effect of Altitude on
Erythropoiesis-Stimulating Agent Dose, Hemoglobin Level, and
Mortality in Hemodialysis Patients,” was published online in the
Journal of Nephrology.
“This study demonstrates that treatments mimicking the effect of
higher altitudes may be beneficial for patients with renal anemia,”
said Brad Maroni, MD, Chief Medical Officer of Akebia. “We believe
that vadadustat may be an effective therapeutic alternative for
renal anemia as it exploits the same mechanism of action used by
the body to naturally adapt to the lower oxygen levels associated
with a moderate increase in altitude. We are currently evaluating
vadadustat in our global Phase 3 program for patients with anemia
related to chronic kidney disease, and look forward to reporting
the results of these trials when they become available.”
The study examined data collected during 2012 after changes were
implemented to both U.S. ESA product labeling and the reimbursement
policy for injectable drugs for dialysis patients, which resulted
in marked ESA dose reductions for the treatment of anemia. The
study found that residence at higher altitude was associated with
improved anemia outcomes compared to those closer to sea level,
including higher mean hemoglobin levels and lower mortality despite
lower proportion of ESA and intravenous iron use. As a result,
treatments that simulate the body’s natural response to higher
altitude may be beneficial to patients with renal anemia.
The retrospective, observational study of over 99,200
hemodialysis patients was conducted in collaboration with DaVita
Clinical Research, a wholly-owned subsidiary of DaVita Inc. The
de-identified dataset contained information on patient
demographics, disease history, comorbidities, dialysis-specific
information for each treatment session, laboratory results, such as
hemoglobin and intravenous anemia medications administered at
dialysis sessions (ESAs and iron). DaVita uses a single ESA
(epoetin alfa), which is delivered intravenously. Patients included
in the analysis had received in-center hemodialysis treatment at a
DaVita facility, and had been receiving dialysis for six months or
more to allow for equilibration of anemia management after dialysis
initiation. The full manuscript is available on the Journal of
Nephrology website at:
http://link.springer.com/article/10.1007%2Fs40620-016-0350-1.
About Anemia Related to Chronic Kidney Disease
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, which occurs
in patients with CKD. Left untreated, anemia significantly
accelerates patients’ overall deterioration of health with
increased morbidity and mortality. Renal 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 oral therapy in development for the treatment of
anemia related to chronic kidney disease in both non-dialysis and
dialysis patients. Akebia has commenced its vadadustat Phase 3
Program, which includes the PRO2TECT studies for non-dialysis
patients with anemia secondary to chronic kidney disease and
INNO2VATE studies for dialysis-dependent patients. For more
information, please visit our website at www.akebia.com.
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, clinical
development plans and potential release of clinical data. 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 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
rate of enrollment in clinical studies of vadadustat; the actual
time it takes to initiate and complete 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 Annual Report on Form 10-Q for
the quarter ended June 30, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160926005483/en/
Akebia:AJ Gosselin, 617-844-6130Manager, Corporate
Communicationsagosselin@akebia.com
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