Akebia Therapeutics (AKBA) Announces Publication of Positive HIF Treatments Data in Renal Anemia

September 26, 2016 7:17 AM EDT

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Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced the publication of a study which concluded that higher altitude is associated with higher hemoglobin levels and lower mortality, despite lower utilization of erythropoiesis-stimulating agent (ESA) and intravenous iron. Treatments that mimic the effect of higher altitude, such as HIF therapies, may provide beneficial effects for renal anemia patients, including improved iron mobilization and erythropoietin synthesis. The article, titled “The Effect of Altitude on Erythropoiesis-Stimulating Agent Dose, Hemoglobin Level, and Mortality in Hemodialysis Patients,” was published online in the Journal of Nephrology.

“This study demonstrates that treatments mimicking the effect of higher altitudes may be beneficial for patients with renal anemia,” said Brad Maroni, MD, Chief Medical Officer of Akebia. “We believe that vadadustat may be an effective therapeutic alternative for renal anemia as it exploits the same mechanism of action used by the body to naturally adapt to the lower oxygen levels associated with a moderate increase in altitude. We are currently evaluating vadadustat in our global Phase 3 program for patients with anemia related to chronic kidney disease, and look forward to reporting the results of these trials when they become available.”

The study examined data collected during 2012 after changes were implemented to both U.S. ESA product labeling and the reimbursement policy for injectable drugs for dialysis patients, which resulted in marked ESA dose reductions for the treatment of anemia. The study found that residence at higher altitude was associated with improved anemia outcomes compared to those closer to sea level, including higher mean hemoglobin levels and lower mortality despite lower proportion of ESA and intravenous iron use. As a result, treatments that simulate the body’s natural response to higher altitude may be beneficial to patients with renal anemia.

The retrospective, observational study of over 99,200 hemodialysis patients was conducted in collaboration with DaVita Clinical Research, a wholly-owned subsidiary of DaVita Inc. The de-identified dataset contained information on patient demographics, disease history, comorbidities, dialysis-specific information for each treatment session, laboratory results, such as hemoglobin and intravenous anemia medications administered at dialysis sessions (ESAs and iron). DaVita uses a single ESA (epoetin alfa), which is delivered intravenously. Patients included in the analysis had received in-center hemodialysis treatment at a DaVita facility, and had been receiving dialysis for six months or more to allow for equilibration of anemia management after dialysis initiation. The full manuscript is available on the Journal of Nephrology website at: http://link.springer.com/article/10.1007%2Fs40620-016-0350-1.

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