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Akebia Therapeutics Announces First Patient Dosed in Phase 2 Basket Trial of Ebribafusp in Rare Complement-Mediated Kidney Diseases

AKBA
  • Akebia Therapeutics has dosed the first patient in an open-label Phase 2 basket trial for ebribafusp targeting IgA nephropathy, lupus nephritis, & C3 glomerulopathy.
  • Initial data from the trial is expected in 2027.
  • Ebribafusp is an investigational anti-C3d factor H fusion protein designed to inhibit complement activation in kidney tissue without suppressing the blood complement system.
  • The trial aims to enroll up to 30 patients who will receive weekly subcutaneous doses for 26 weeks followed by a long-term extension study.
  • The primary endpoint is the incidence of adverse events, while secondary endpoints include changes in proteinuria, kidney function (eGFR), & pharmacokinetics.
  • The study will measure blood & urine complement biomarkers to assess tissue-specific inhibition of complement activity.
  • Ebribafusp (formerly AKB-097) was acquired by Akebia from Q32 Bio in November 2025.
  • Previous Phase 1 trials in healthy volunteers showed the drug was generally well-tolerated with minimal anti-drug antibodies.
  • Trial details are available on ClinicalTrials.gov under identifier NCT06419205.