AKBA News & Events

Akebia and U.S. Renal Care announced the decision by USRC Kidney Research to stop the Vafseo Outcomes In Center Experience, or VOICE, trial following a planned interim analysis. The primary investigator made the decision to stop the study after a recommendation from the Independent Data Monitoring Committee and Trial Steering Committee based on the prespecified stopping criteria and supported by findings of significantly improved safety outcomes in patients treated with Vafseo dosed three times weekly versus an erythropoiesis-stimulating agent. The VOICE trial enrolled 2,116 patients and was designed as a randomized, open-label, active controlled, non-inferiority trial sponsored by USRC to measure the safety of Vafseo administered TIW versus standard-of-care ESA using a hierarchical composite endpoint of mortality and hospitalization rates. Results of the planned interim analysis as of June 1, the data cutoff date, demonstrated that the trial met the predefined stopping criteria with a win odds of 1.16, establishing non-inferiority and superiority of the primary composite endpoint. The results further demonstrated a statistically significant decrease in hospitalizations with Vafseo versus ESA. There was no statistically significant difference between mortality rates with Vafseo versus ESA.

Reports Q1 revenue $53.54M, consensus $51.57M. "The number of patients on Vafseo increased through the start of the year, and we are further encouraged by trends suggesting continued growth as we leverage improved patient access and adherence as dialysis organizations implement observed dosing protocols," said John P. Butler, Chief Executive Officer of Akebia. "Increasing the breadth and depth of Vafseo prescribing, complemented by our efforts to generate data that will potentially demonstrate its additional clinical benefits, is critical to achieving our goal to make Vafseo standard of care for patients on dialysis. Separately, I'm pleased with the progress made to advance our clinical pipeline of kidney disease programs, now with two clinical programs enrolling, including a Phase 2 clinical trial of praliciguat in FSGS. We remain on track with plans to initiate a Phase 2 open-label rare kidney disease basket study in the second half of 2026, evaluating AKB-097 in IgA nephropathy, lupus nephritis and C3 glomerulopathy. These efforts were recently highlighted as part of our virtual R&D Day, where key medical experts reinforced the potential of our expanding pipeline."

Akebia Therapeutics announced the first participants have been dosed in a Phase 1 clinical trial of AKB-9090, an internally developed hypoxia-inducible factor-prolyl hydroxylase inhibitor being evaluated for the treatment of cardiac surgery-associated acute kidney injury.