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Akebia Announces Presentation of Vadadustat Phase 2 Dialysis Data at American Society of Nephrology Kidney Week 2015 Annual Meeting

- Vadadustat Maintained Stable Hemoglobin Levels in All Three Dose Cohorts Following Conversion from rESA Therapy -





- Vadadustat Demonstrated Sustained Improvements in Iron Mobilization -

CAMBRIDGE, Mass., Nov. 7, 2015 (GLOBE NEWSWIRE) -- 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), announced that Phase 2 results for vadadustat in dialysis patients with anemia related to chronic kidney disease (CKD) were presented in a late-breaker poster presentation at the American Society of Nephrology (ASN) Kidney Week 2015 annual meeting, which is being held in San Diego, California from November 3-8, 2015. Dr. Volker H. Haase, Professor of Medicine, Division of Nephrology and Hypertension at Vanderbilt University Medical Center, was the first author of the presentation which is available online at www.akebia.com/media/publications.

The Phase 2 study achieved its primary endpoints of maintaining stable hemoglobin levels over 16 weeks of treatment in all three cohorts of patients converting from recombinant erythropoiesis-stimulating agents (rESA) to vadadustat, as shown in the chart below ("Mean Hemoglobin Levels Over Time by Dose Cohort") and in the poster available online. In addition, the study also demonstrated sustained improvements in iron mobilization across all three cohorts, shown by an elevation in Total Iron Binding Capacity (TIBC), also illustrated below and in the poster. These results are consistent with those achieved in previous vadadustat studies.

"The results of the study highlight the potential of vadadustat to effectively and safely treat anemia in dialysis patients switching from injectable rESA therapy," stated Dr. Haase. "The consistency of the data across all three cohorts suggests that vadadustat may play an important role in the evolving treatment landscape for anemia, which is focused on controlling and maintaining hemoglobin levels within a desired range, while minimizing excursions above 13g/dL."

Vadadustat was well tolerated among patients in all three dose cohorts. This study demonstrated a favorable safety profile of vadadustat with no drug-related serious adverse events and no deaths. Treatment-emergent adverse events with vadadustat were balanced across the three cohorts. Thirteen subjects, or 13.8% of patients, reported serious adverse events (SAEs), at the low end of what was expected for this patient population (between 13% and 17%).

"The data reinforce the potential benefits of vadadustat for patients with anemia related to CKD and, together with the data from our studies in non-dialysis patients, demonstrate that vadadustat may offer a potentially safer and more effective treatment option for CKD patients," said Brad Maroni, M.D., Chief Medical Officer at Akebia. "We look forward to building on these data with our global Phase 3 program, and remain on track to initiate the PRO2TECT™ clinical program in non-dialysis CKD patients this year."

Graphs accompanying this release are available at

http://media.globenewswire.com/cache/37519/file/38600.pdf

http://media.globenewswire.com/cache/37519/file/38601.pdf

About the Phase 2 Study Design of Vadadustat in Dialysis Patients with Anemia Related to CKD

The Phase 2 multi-center, open-label study evaluated 94 patients over 16 weeks of treatment, at 20 dialysis centers in the United States, including an assessment of HGB response to the starting dose of vadadustat during the first 8 weeks, followed by an assessment of HGB response to algorithm-guided dose adjustments of vadadustat during the subsequent 8 weeks of treatment. The study enrolled three cohorts, each consisting of approximately 30 CKD patients with anemia undergoing dialysis who were switched from injectable rESA therapy to vadadustat. Patients in the first two cohorts received once daily doses of vadadustat, while patients in the third cohort received vadadustat three times per week in conjunction with their hemodialysis schedule.

About Vadadustat

Vadadustat is an oral therapy currently in development for the treatment of anemia related to chronic kidney disease (CKD). Vadadustat 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. Vadadustat 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, vadadustat raises hemoglobin levels predictably and sustainably, with a dosing regimen that allows for a gradual and controlled titration. Vadadustat 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 the United States have CKD, with an estimated 1.8 million of these patients suffering from anemia. 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, 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 rESAs, 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 HIF biology. The company has completed Phase 2 development of its lead product candidate, vadadustat, an oral therapy for the treatment of anemia related to CKD in both non-dialysis and dialysis patients, and plans to initiate its Phase 3 program in 2015.

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, dosing and benefits of vadadustat, the development plan for vadadustat, and the initiation of the Phase 3 program. 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 our Phase 3 studies and the availability of financing to cover such cost; the timing and content of decisions made by the FDA and other regulatory authorities; the actual time it takes to prepare for and initiate Phase 3 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, 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.

CONTACT: Investors: Ed Joyce Phone: (617) 844-6130 Email: ejoyce@akebia.com Media: Argot Partners Eliza Schleifstein Phone: (917) 763-8106 Email: Eliza@argotpartners.com

Source:Akebia Therapeutics