Press Release
Akebia Announces Dosing of First Patient in Phase 2 Study of AKB-6548 in Patients with Anemia Related to Chronic Kidney Disease Undergoing Dialysis
"With this study, we are expanding our clinical experience with AKB-6548
beyond the non-dialysis CKD setting to include the treatment of anemia
in patients with end-stage renal disease receiving dialysis," said
The Phase 2 multi-center, open-label study will enroll approximately 60 patients with anemia related to CKD who are undergoing dialysis. The study will evaluate patients for a total of 16 weeks of treatment, including an assessment of hemoglobin (HGB) response to AKB-6548 during an initial eight-week dosing period, followed by an assessment of HGB response to algorithm-guided dose adjustments of AKB-6548 during an additional eight weeks of treatment. Secondary objectives include pharmacodynamic response, safety, and tolerability of AKB-6548 in this patient population. Patients will receive AKB-6548 in place of their existing injectable rESA therapy. Data from this clinical study are expected in the third quarter of 2015.
"The initiation of this study is an important milestone in our
development program for AKB-6548," said
Akebia is also evaluating AKB-6548 in a Phase 2b trial for the treatment of anemia related to CKD in non-dialysis patients, with results expected in the fourth quarter of 2014.
About AKB-6548
AKB-6548 is a once-daily oral therapy currently in development for the treatment of anemia related to CKD. AKB-6548 is designed to stabilize hypoxia-inducible factor (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. AKB-6548 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. Due to its specific HIF effect, AKB-6548 has the potential to restore coordination of the interdependent processes of iron mobilization and EPO production that are disrupted in patients with anemia related to CKD.
A HIF stabilizer with best-in-class potential, AKB-6548 may raise hemoglobin levels and RBC count predictably and sustainably, with an optimal safety profile and a dosing regimen that allows for a gradual and controlled titration. Furthermore, AKB-6548 may improve iron mobilization, potentially eliminating intravenous iron administration and reducing the overall need for iron supplementation.
About Anemia Related to CKD
Representing a growing global health concern, patients with chronic kidney disease progressively lose kidney function resulting in the development of several serious medical conditions including anemia. Left untreated, anemia significantly accelerates patients' overall deterioration of health with increased morbidity and mortality. Anemia results from the body's inability to coordinate RBC production in response to lower oxygen levels due to the progressive loss of kidney function.
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 AKB-6548, the development plan for the Phase
2 study in dialysis patients with anemia related to CKD, and the
expected timing of the announcement of data from the Phase 2 study and
the Phase 2b study. 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 AKB-6548; the funding
required to develop Akebia's product candidates and operate the company,
and the actual expenses associated therewith; the content of decisions
made by the FDA and other regulatory authorities; the rate of enrollment
in the Phase 2 study; the actual time it takes to complete the Phase 2
and Phase 2b studies and analyze the data; 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 AKB-6548. 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
Source:
Investors:
Senior Director, Investor Relations and Corporate
Communications
njones@akebia.com
or
Media:
liz.falcone@fkhealth.com
Source:
News Provided by Acquire Media
Akebia Therapeutics, Inc.
245 First Street, Suite 1400
Cambridge, MA 02142
+1 617.871.2098 phone
+1 617.871.2099 fax