Ebribafusp (AKB-097 (ADX-097))

Aug. 3, 2026: Akebia Therapeutics (NASDAQ: AKBA) announced initiation of an open-label Phase 2 basket trial of ebribafusp (formerly AKB-097/ADX-097) in rare complement-mediated kidney diseases: IgA nephropathy, lupus nephritis, and C3 glomerulopathy. The study plans to enroll up to 30 patients, with once-weekly subcutaneous dosing for 26 weeks and a long-term extension for responders.

The primary endpoint is adverse events; secondary endpoints include change in proteinuria by UPCR, kidney function by eGFR, and pharmacokinetics. The trial will also assess blood and urine complement biomarkers to evaluate whether ebribafusp reduces complement activity in kidney tissue without inhibiting complement in the blood. Akebia expects to report initial data in 2027. ClinicalTrials.gov identifier: NCT06419205.

The release states that in a completed Phase 1 study in healthy volunteers, weekly 450 mg subcutaneous dosing achieved desired exposures for predicted tissue complement inhibition without blood complement inhibition, and ebribafusp was generally well tolerated with minimal anti-drug antibodies. Akebia also noted it acquired global rights to ebribafusp from Q32 Bio in November 2025.