Akebia Therapeutics Acquires Complement‑Inhibitor AKB‑097, Targets Rare Kidney Diseases in Phase 2 Trials

AKBA
December 01, 2025

Akebia Therapeutics announced the purchase of the global rights to the tissue‑targeted complement‑inhibitor candidate AKB‑097 from Q32 Bio. The deal was structured with a $7 million upfront payment, a $3 million milestone payment due six months after closing, and additional tiered royalties that could bring total milestone payments to $592 million. The transaction gives Akebia a next‑generation C3d‑Factor H fusion protein that is designed to inhibit complement activation only in diseased tissue, potentially reducing systemic infection risk compared with existing complement inhibitors.

AKB‑097 is a C3d‑Factor H fusion protein that homes to inflamed kidney tissue, blocking complement activation at the site of injury while sparing healthy organs. This tissue‑targeted mechanism is expected to improve safety and efficacy in complement‑mediated kidney disorders, a class of diseases that currently lack robust therapeutic options. The candidate is already in preclinical development and is poised to enter a Phase 2 basket trial in the second half of 2026.

The planned Phase 2 study will enroll patients with rare complement‑mediated kidney diseases, including focal segmental glomerulosclerosis (FSGS), and will evaluate safety, tolerability, and preliminary efficacy. Initial data are expected in 2027, and the trial will be conducted in parallel with Akebia’s other rare‑kidney pipeline asset, praliciguat, which is also being advanced for FSGS. By pursuing two complementary modalities, Akebia aims to broaden its therapeutic portfolio and address unmet needs in a high‑margin specialty market.

The acquisition aligns with Akebia’s strategy to diversify beyond its commercial‑stage products, Vafseo and Auryxia. Vafseo, launched in the U.S. in January 2025, has driven strong revenue growth, while Auryxia continues to generate steady sales for phosphate control and iron‑deficiency anemia in chronic kidney disease patients. In Q3 2025, Akebia reported $58.8 million in revenue, up 57% from $37.4 million in Q3 2024, largely driven by Vafseo and Auryxia sales. The AKB‑097 acquisition adds a high‑potential asset that could unlock new revenue streams and reinforce the company’s position in the kidney‑disease specialty space.

CEO John P. Butler said the move “strengthens our rare‑kidney pipeline and positions Akebia to deliver innovative therapies to patients with limited options.” Analysts have noted the company’s strong commercial momentum and the strategic fit of AKB‑097, viewing the acquisition as a catalyst for future growth in a niche but expanding market.

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