CAMBRIDGE, MA, USA I May 24, 2017 I 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 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.”
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 here.
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 www.akebia.com.
SOURCE: Akebia Therapeutics
Post Views: 23
CAMBRIDGE, MA, USA I May 24, 2017 I 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 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.”
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 here.
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 www.akebia.com.
SOURCE: Akebia Therapeutics
Post Views: 23
