Akebia Therapeutics Inc. announced positive top-line results from its Phase 2b placebo-controlled trial of AKB-6548 in non-dialysis patients with anemia related to chronic kidney disease. The study achieved its primary endpoint and AKB-6548 was generally well tolerated, confirming that the once-daily, oral therapy can successfully increase and maintain hemoglobin levels, Akebia said in a release.
The 20-week study enrolled 209 patients, who were randomized 2:1 to active treatment or placebo. The results showed that 54.9% of patients who received AKB-6548 met the primary endpoint versus 10.3% in the placebo group (p<0.0001). The primary endpoint was defined as achieving or maintaining a mean Hgb ≥ 11.0 g/dL or increasing Hgb by ≥ 1.2 g/dL above the pre-treatment value as measured by the mean Hgb value at weeks 19 and 20.
The study also was designed to evaluate the ability of the dose titration algorithm to minimize Hgb excursions ≥ 13.0 g/dL. Only six patients (4.4%) treated with AKB-6548 experienced an excursion above this threshold. This result supports the adaptive dosing approach used in the study, which enabled robust Hgb increases while minimizing excursions, Akebia said.
“These Phase 2b results are impressive, demonstrating a sustained effect on hemoglobin throughout the twenty weeks of treatment,” said Brad Maroni, MD, Senior Vice President and Chief Medical Officer at Akebia. “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.”