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news.Akebia Therapeutics has reported positive top-line results from its Phase IIb placebo-controlled trial of its once-daily, oral therapy, AKB-6548, in non-dialysis patients with anemia related to chronic kidney disease (CKD).
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AKB-6548 is designed to stabilize hypoxia inducible factor (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 HIF prolyl hydroxylase (HIF-PH) enzyme.
The trial met its primary endpoint and the results showed that AKB-6548 was generally well tolerated, confirming that the once-daily, oral therapy can successfully increase and maintain haemoglobin (HGB) levels.
A total of 209 patients were enrolled in the 20-week trial and they were randomized 2:1 to active treatment or placebo.
Akebia senior vice-president and chief medical officer Dr Brad Maroni said: "These Phase IIb results are impressive, demonstrating a sustained effect on haemoglobin 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 haemoglobin levels in a safe, predictable and controlled manner."
Results showed that 54.9% of patients who received AKB-6548 met the primary endpoint versus 10.3% in the placebo group.
The trial’s primary endpoint was defined as achieving or maintaining a mean HGB = 11.0g/dL or increasing HGB by = 1.2g/dL above the pre-treatment value as measured by the mean HGB value at weeks 19 and 20.
AKB-6548 is also being evaluated in a Phase II clinical trial to treat dialysis patients with anemia related to CKD. Results from that study are expected in the third quarter of 2015.