Akebia Posts Topline Phase 2B Trial Results Of CKD Drug

Akebia Therapeutics, a biopharmaceutical company developing treatments for kidney disease based on hypoxia inducible factor (HIF) biology, reported positive topline results from the Phase 2B trial of AKB-6548 in non-dialysis patients with anemia caused by chronic kidney disease (CKD).

AKB-6548 is a once daily oral therapy being developed for the treatment of CKD-related anemia. The drug stabilizes HIF which is a transcription factor that modulates gene expression involved with red blood cell (RBC) production in response to oxygen level changes. AKB-6548 essentially mimics the body’s response to increases in altitude. The company said the drug may be able to raise hemoglobin levels and RBC count, as well as improve iron mobilization to treat CKD-related anemia.

Results from the double-blind, placebo controlled, randomized Phase 2b study showed that 54.9 of patients who received AKB-6548 successfully maintained HGB levels compared to 10.3 percent of those who took placebo. Brad Maroni, SVP and CMO at Akebia, said, “These Phase 2b results are impressive, demonstrating a sustained effect on hemoglobin throughout the twenty weeks of treatment. The challenges associated with current treatment options are well documented. The data underscore the potential of AKB-6548 to effectively raise and maintain hemoglobin levels in a safe, predictable, and controlled manner.”

CKD-related anemia occurs when progressive kidney function loss causes a loss of oxygen and the body is incapable of balancing RBC production. The condition affects an estimated 1.8 million among the 30 million people in the U.S. who have CKD. Anemia eventually causes faster health deterioration along with increased morbidity and mortality.

While AKB-6548 is expected to possess blockbuster potential according to UBS analyst Matthew Roden, the news of serious adverse events (SAEs), which included one death, caused the company’s shares to slip. Roughly 24 percent of SAEs were observed in the active treatment group compared to 15.3 percent of the placebo group, Reuters reports. The company stated that patients in the advanced stages of CKD have many comorbidities and that the overall profile of the trial participants was consistent with the general population of patients in the later stages of CKD.

John P. Butler, President and CEO of Akebia, said, “We are extremely pleased with the results of our Phase 2b study… We look forward to discussing these data with U.S. and European regulatory agencies in preparation for launching Phase 3 registration studies next year.”

The company said it will present the detailed safety and efficacy results of the Phase 2B study at an upcoming medical meeting.