Akebia Doses First Patients in Phase 1 Trial for Cardiac Surgery Kidney Injury Drug

Event summary

  • Akebia Therapeutics dosed first participants in Phase 1 trial of AKB-9090, an intravenous HIF-PH inhibitor for cardiac surgery-associated acute kidney injury (AKI).
  • The randomized, double-blind, placebo-controlled study will enroll up to 70 healthy adults across single and multiple ascending dose cohorts.
  • Top-line data from the trial is expected in early 2027.
  • Akebia also highlighted progress in its pipeline, including praliciguat in Phase 2 for focal segmental glomerulosclerosis and AKB-097 planned for Phase 2 in rare kidney diseases.

The big picture

Akebia's Phase 1 trial initiation for AKB-9090 reflects its strategic focus on acute kidney injury, a high-unmet-need area in cardiac surgery. The company is expanding its pipeline beyond chronic kidney disease, positioning itself as a key player in both acute and chronic kidney disease treatments. Success in this trial could validate its HIF-PH inhibitor platform, potentially attracting partnerships or investment.

What we're watching

Clinical Progress
Whether AKB-9090 demonstrates safety and tolerability in Phase 1, paving the way for further development in AKI.
Pipeline Diversification
How Akebia balances multiple clinical programs while advancing AKB-9090 through Phase 1.
Regulatory Pathway
The pace at which Akebia can secure regulatory approvals for its expanding pipeline of kidney disease treatments.