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 <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.akebia.com&amp;esheet=51564212&amp;newsitemid=20170524005150&amp;lan=en-US&amp;anchor=Akebia+Therapeutics&amp;index=1&amp;md5=370acda291286f73266b341428b4ace1" rel="nofollow" rel="nofollow">Akebia 
 Therapeutics</a>, Inc. 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 dosed the first patient in its Phase 2 FO2RWARD 
 study of vadadustat in dialysis-dependent chronic kidney disease 
 (DD-CKD) patients who are hyporesponsive to erythropoiesis-stimulating 
 agents (ESAs). Vadadustat is an oral HIF stabilizer currently in Phase 3 
 development for the treatment of anemia related to chronic kidney 
 disease.
 
 
 FO2RWARD is a randomized, open-label study that will assess 
 the safety and efficacy of vadadustat versus an active comparator, 
 epoetin alfa, in approximately 80 DD-CKD patients with ESA hyporesponse 
 in the United States. The primary outcome measure will be the percent 
 reduction in previously prescribed epoetin alfa dose and change in 
 hemoglobin level over the course of the study. Akebia expects to report 
 data from FO2RWARD by the end of 2018.
 
 
 "Patients who do not adequately respond to ESA treatment represent 
 approximately 10-15% of DD-CKD patients, yet hyporesponders account for 
 30-40% of total ESA use," said John P. Butler, President and Chief 
 Executive Officer of Akebia. "These patients have demonstrated a 
 persistently higher risk of mortality than non-hyporesponders, and 
 represent a high unmet need. We believe that vadadustat may provide a 
 solution for these patients, and we anticipate results from FO2RWARD 
 next year.&#34;
 
 
 In a previously published retrospective analysis conducted by Akebia in 
 collaboration with DaVita Clinical Research, a wholly-owned subsidiary 
 of DaVita HealthCare Partners Inc., persistently greater mortality, 
 greater iron and ESA use, and lower hemoglobin levels were observed in 
 DD-CKD patients with ESA hyporesponse compared to non–ESA hyporesponsive 
 patients. The article, titled "Spectrum and Burden of 
 Erythropoiesis-Stimulating Agent Hyporesponsiveness Among Contemporary 
 Hemodialysis Patients," was published online in the American Journal 
 of Kidney Diseases, and is available <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.ajkd.org%2Farticle%2FS0272-6386%2816%2930282-7%2Ffulltext&amp;esheet=51564212&amp;newsitemid=20170524005150&amp;lan=en-US&amp;anchor=here&amp;index=2&amp;md5=288844b0168a4302a0807a49ae909fa9" rel="nofollow" rel="nofollow">here</a>.
 
 
 About Vadadustat
 
 
 Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer 
 currently in Phase 3 development for the treatment of anemia related to 
 chronic kidney disease. Vadadustat exploits the same mechanism of action 
 used by the body to adapt naturally 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 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, 
 investigational therapy in development for the treatment of anemia 
 related to chronic kidney disease in both non-dialysis and dialysis 
 patients. Akebia's global Phase 3 program for vadadustat, which includes 
 the PRO2TECT studies for non-dialysis patients with anemia 
 secondary to chronic kidney disease and the INNO2VATE studies 
 for dialysis-dependent patients, is currently ongoing. For more 
 information, please visit our website at <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.akebia.com&amp;esheet=51564212&amp;newsitemid=20170524005150&amp;lan=en-US&amp;anchor=www.akebia.com&amp;index=3&amp;md5=948183f8d4ee5d1ebc898ba41c1b3392" rel="nofollow" rel="nofollow">www.akebia.com</a>.
 
 
 Forward-Looking Statements
 
 
 This press release includes forward-looking statements. Such 
 forward-looking statements include those about Akebia&#39;s strategy, future 
 plans and prospects, including statements regarding the potential 
 indications and benefits of vadadustat, and the expected timing of the 
 hyporesponder study 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 program for vadadustat; 
 the funding required to develop Akebia&#39;s product candidates and operate 
 the company, and the actual expenses associated therewith; the actual 
 costs incurred in the global Phase 3 studies of vadadustat, including 
 the hyporesponder study, and the availability of financing to cover such 
 costs; the timing of any additional studies initiated by Akebia or its 
 collaborators for vadadustat; the timing and content of decisions made 
 by 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&#39;s ability to obtain, maintain and enforce patent 
 and other intellectual property protection for vadadustat around the 
 world. Other risks and uncertainties include those identified under the 
 heading "Risk Factors" in Akebia&#39;s Report on Form 10-Q for the quarter 
 ended March 31, 2017, 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.
 
 
 
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Press Releases

Akebia Initiates Phase 2 FO2RWARD Study of Vadadustat in Dialysis Patients with Anemia Related to Chronic Kidney Disease Hyporesponsive to Treatment with Erythropoiesis-Stimulating Agents - Akebia Therapeutics (NASDAQ:AKBA)

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Akebia Initiates Phase 2 FO2RWARD Study of Vadadustat in Dialysis Patients with Anemia Related to Chronic Kidney Disease Hyporesponsive to Treatment with Erythropoiesis-Stimulating Agents



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