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Press Release

Akebia Announces Presentations at the Upcoming American Society of Nephrology Kidney Week 2016 Annual Meeting

Akebia Therapeutics,Inc.
Posted on: 17 Oct 16

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 today that additional supportive data from the vadadustat development program in both dialysis-dependent chronic kidney disease patients and non-dialysis dependent chronic kidney disease patients will be presented at the upcoming American Society of Nephrology (ASN) Kidney Week 2016 annual meeting, taking place in Chicago, Ill. from November 15-20, 2016. The company’s global Phase 3 program for patients with anemia associated with chronic kidney disease is currently enrolling patients.

Akebia presentation details at ASN:

Thursday, November 17, 2016, 10:00 a.m. – 12:00 p.m.

Title: Efficacy and Dose Requirements of Vadadustat are Independent of Systemic Inflammation and Prior Erythropoiesis-Stimulating Agent (ESA) Dose in Patients With Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)

Abstract Program #: TH-PO907
Session Title: CKD: Clinical Trials
Location: Exhibit Hall
 

Thursday, November 17, 2016, 10:00 a.m. – 12:00 p.m.

Title: Vadadustat Maintains Hemoglobin (Hb) Levels in Dialysis Dependent Chronic Kidney Disease (DD-CKD) Patients Independent of Systemic Inflammation or Prior Dose of Erythropoiesis Stimulating Agent (ESA)

Abstract Program #: TH-PO960
Session Title: Standard Hemodialysis for ESRD
Location: Exhibit Hall
 

Saturday, November 19, 2016, 10:00 a.m. – 12:00 p.m.

Title: Pharmacokinetics (PK), Pharmacodynamics, and Safety of Single and Multiple Oral Doses of Vadadustat in Healthy Japanese and Caucasian Subjects)

Abstract Program #: SA-PO506
Session Title: Pharmaco: Kinetics, Dynamics, Genomics
Location: Exhibit Hall

The posters will be made available at the time of the presentations by accessing Akebia's website at: http://akebia.com/media/publications/.

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 planned presentations of 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161017005578/en/

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Last updated on: 17/10/2016

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