CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 that the company has initiated a global Phase 3 program to evaluate vadadustat for a second indication in renal anemia. Known as INNO2VATE, the program consists of two studies designed to evaluate vadadustat in patients with anemia related to chronic kidney disease who are undergoing dialysis. Akebia’s ongoing Phase 3 PRO2TECT program in non-dialysis dependent patients with anemia related to chronic kidney disease commenced at the end of last year.
“The launch of the INNO2VATE program represents an important milestone for our global vadadustat Phase 3 program,” stated John P. Butler, President and Chief Executive Officer of Akebia. “Similar to our parallel Phase 3 PRO2TECT program in patients who are not currently on dialysis, INNO2VATE is designed to demonstrate the best-in-class potential of vadadustat to treat patients who are suffering from anemia related to chronic kidney disease.”
The INNO2VATE program includes two separate studies and will collectively enroll approximately 2,600 dialysis-dependent patients with anemia related to chronic kidney disease. Both studies will include a 1:1 randomization and an open label, active-control, non-inferiority design. Primary endpoints include an efficacy assessment of the hemoglobin response and an assessment of cardiovascular safety as measured by standard major adverse cardiovascular events (MACE) criteria. The INNO2VATE-Correction study will evaluate patients not currently being treated with recombinant erythropoiesis stimulating agents (rESAs). The INNO2VATE-Conversion study will evaluate patients currently receiving rESA who will be converted to either vadadustat or the active control, with the goal of maintaining their baseline hemoglobin levels.
About Vadadustat
Vadadustat is an oral hypoxia-inducible
factor (HIF) stabilizer with best-in-class potential for the treatment
of anemia related to chronic kidney disease. Vadadustat, currently in
development, 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
production to increase red blood cell production and, ultimately,
improve oxygen delivery.
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 and the plans for the INNO2VATE and PRO2TECT
Phase 3 programs. 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
March 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.
