Press Release
Akebia Completes Enrollment in the Two Planned Cohorts of its Phase 2 Study of AKB-6548 in Patients with Anemia Related to Chronic Kidney Disease Undergoing Dialysis
-- Enrollment Completed Ahead of Schedule --
-- Expanding Trial to Include Third Cohort, with Top-Line Data Still Expected in Third Quarter of 2015 --
"The rate of enrollment in this Phase 2 trial reflects the enthusiasm
surrounding AKB-6548 as a potential treatment for CKD patients
undergoing dialysis who are suffering from anemia," stated
The Phase 2 multi-center, open-label study has already enrolled two cohorts, each consisting of 30 patients with anemia undergoing dialysis who were switched from injectable recombinant erythropoiesis-stimulating agent therapy to once-daily, oral doses of AKB-6548. The trial will now include an additional cohort of 30 patients who will receive AKB-6548 three times per week. The study will evaluate a total of 90 patients for 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.
"Completing enrollment in the two cohorts ahead of schedule represents a
significant achievement for the AKB-6548 program, and allows us to more
fully explore the range of dosing options for renal anemia patients
undergoing dialysis as we advance AKB-6548 toward commercialization,"
stated
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 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.
As a HIF stabilizer with best-in-class potential, AKB-6548 raises hemoglobin levels predictably and sustainably, with a dosing regimen that allows for a gradual and controlled titration. AKB-6548 has been shown to improve iron mobilization, potentially eliminating the need for intravenous iron administration and reducing the overall need for iron supplementation.
About Anemia Related to CKD
Approximately 30 million people in
About
Forward-Looking Statement
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 development plan
for the Phase 2 study in dialysis patients with anemia related to CKD
including plans for a third cohort in the study, the potential
indications and benefits of AKB-6548, the expected timing of results
from the Phase 2 study, and the potential of AKB-6548 to be a
"best-in-class" product. 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 timing and 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 study 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
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Akebia Therapeutics, Inc.
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