CAMBRIDGE, Mass., Oct. 28, 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), today announced that data from the vadadustat (formerly AKB-6548) development program will be presented at the upcoming American Society of Nephrology (ASN) Kidney Week 2015 annual meeting in San Diego, California from November 3-8, 2015.
| Late-Breaker Poster Presentation: | |
| Saturday, November 7, 2015, 10:00 AM - 12:00 PM | |
| Title: | Vadadustat, a Novel Oral Treatment for Anemia of Chronic Kidney Disease, Maintains Stable Hemoglobin Levels in Dialysis Patient Converting from Erythropoiesis-Stimulating Agents (Abstract Program #SA-PO1110) |
| Session Title: | Late-Breaking Clinical Trial Posters |
| Location: | Exhibit Hall |
| Oral Presentation: | |
| Thursday, November 5, 2015, 4:30 PM - 6:30 PM, Presentation 5:54 PM | |
| Title: | Hemoglobin (Hb) Response in a Phase 2b Study of AKB-6548 for the Treatment of Anemia in Patients with Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD) (Abstract Program #TH-OR038) |
| Session Title: | Clinical Trials in CKD: Pursuing a New Horizon |
| Location: | Room 25 |
| Poster Sessions: | |
| Thursday, November 5, 2015, 10:00 AM - 12:00 PM | |
| Title: | Vadadustat Demonstrates Controlled Hemoglobin Response in a Phase 2b Study for the Treatment of Anemia in Patients with Non-Dialysis Dependent Chronic Kidney Disease (Abstract Program #TH-PO649) |
| Session Title: | CKD: Clinical Trials |
| Location: | Exhibit Hall |
| Saturday, November 7, 2015, 10:00 AM - 12:00 PM | |
| Title: | Dose Exposure Relationship of Vadadustat is Independent of the Level of Renal Function (Abstract Program #SA-PO537) |
| Session Title: | Drug Pharmacokinetics and Pharmacogenomics in CKD |
| Location: | Exhibit Hall |
| Collaborative Poster Session Details: | |
| Thursday, November 5, 2015, 10:00 AM - 12:00 PM | |
| Title: | The Effect of Altitude on Erythropoiesis-Stimulating Agent Dose, Hemoglobin Level, and Mortality in Hemodialysis Patients (Abstract Program #TH-PO936) |
| Session Title: | Dialysis: Epidemiology, Outcomes, and Clinical Trials: Noncardiovascular - I |
| Location: | Exhibit Hall |
| Collaboration with Davita Clinical Research | |
| Saturday, November 7, 2015, 10:00 AM - 12:00 PM | |
| Title: | Erythropoietin-Stimulating Agent (ESA) Hyporesponse (ESAhr) Is Associated with Persistently Elevated Mortality Among Hemodialysis (HD) Patients (Abstract Program #SA-PO800) |
| Session Title: | Dialysis: Anemia and Iron Metabolism |
| Location: | Exhibit Hall |
| Collaboration with Davita Clinical Research | |
| Saturday, November 7, 2015, 10:00 AM - 12:00 PM | |
| Title: | Variability in Hemoglobin (Hb) Levels in Hemodialysis (HD) Patients in the Current Era (Abstract Program #SA-PO824) |
| Session Title: | Dialysis: Anemia and Iron Metabolism |
| Location: | Exhibit Hall |
| Collaboration with Chronic Disease Research Group (CDRG) | |
The clinical posters will be available on Akebia’s website (www.akebia.com) in the Media section under the Publications tab.
About Vadadustat (Formerly AKB-6548)
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.
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, and the presentation of data at the ASN Kidney Week 2015 annual meeting. 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 program and the availability of financing to cover such cost; the timing and content of decisions made by the FDA, EMA and other regulatory authorities; the actual time it takes to prepare for and initiate the Phase 3 program, including initiating sites and enrolling patients; 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 (617) 844-6130 Ejoyce@akebia.com Media: Argot Partners Eliza Schleifstein (917) 763-8106 Eliza@argotpartners.com
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