Akebia Therapeutics Initiates Phase 1 Trial of AKB-9090 for Cardiac Surgery-Associated Acute Kidney Injury
核心洞察
Akebia Therapeutics has dosed the first participants in a Phase 1 clinical trial of AKB-9090, a hypoxia-inducible factor-prolyl hydroxylase inhibitor for treating cardiac surgery-associated acute kidney injury.
The randomized, double-blind, placebo-controlled study will enroll up to 70 healthy participants to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous AKB-9090.
The company plans to report top-line data from the Phase 1 trial in early 2027, marking progress in addressing acute care conditions with significant unmet medical need.
Akebia Therapeutics has achieved a significant milestone in its kidney disease pipeline by dosing the first participants in a Phase 1 clinical trial of AKB-9090, an internally developed hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor being evaluated for the treatment of cardiac surgery-associated acute kidney injury (AKI). The Cambridge, Massachusetts-based biopharmaceutical company announced the development on April 13, 2026.
Trial Design and Objectives
The Phase 1 study follows a randomized, double-blind, placebo-controlled design with single and multiple ascending dose (SAD/MAD) cohorts. The trial will enroll up to 70 participants who will be randomized to receive either AKB-9090 or placebo across sequential dose-escalation cohorts. The drug will be administered intravenously to healthy adult participants.
The primary endpoints focus on safety and tolerability assessments, including the incidence of treatment-emergent adverse events and changes in clinical laboratory parameters, vital signs, and electrocardiograms. The study is also designed to evaluate the pharmacokinetics and pharmacodynamics of AKB-9090.
Clinical Development Timeline
"AKB-9090 has been internally developed leveraging our team's extensive expertise in HIF-PH biology, and we believe is a promising product candidate with the potential to treat acute care conditions with significant unmet need such as AKI," said John P. Butler, Chief Executive Officer of Akebia. The company plans to report top-line data from the Phase 1 trial in early 2027.
Expanding Kidney Disease Pipeline
AKB-9090 represents one component of Akebia's broader clinical-stage kidney disease portfolio, which the company introduced in late 2025. The pipeline includes three distinct therapeutic approaches targeting different nephrology conditions.
Praliciguat, a soluble guanylate cyclase stimulator, is currently being evaluated in a Phase 2 clinical trial for focal segmental glomerulosclerosis. Additionally, AKB-097 (搜索), described as a next-generation tissue-targeted complement inhibitor, is planned to enter a Phase 2 basket trial in the second half of 2026. This basket trial will target rare kidney diseases including IgA nephropathy, lupus nephritis, and C3 glomerulopathy.
Therapeutic Focus and Mechanism
The development of AKB-9090 builds on Akebia's established expertise in HIF-PH biology. As a HIF-PH inhibitor, AKB-9090 targets the hypoxia-inducible factor pathway, which plays a crucial role in cellular responses to oxygen availability. This mechanism positions the drug candidate to address acute care conditions, particularly cardiac surgery-associated AKI, which represents an area of significant unmet medical need.
Akebia Therapeutics, founded in 2007, describes itself as a fully integrated biopharmaceutical company dedicated to improving the lives of people impacted by kidney disease. The initiation of the AKB-9090 Phase 1 trial marks a key advancement in the company's mission to develop innovative therapies for nephrology patients.