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Akebia Announces Establishment of Rare Kidney Disease Pipeline

Acquires next generation tissue-targeted C3d-Factor H fusion protein complement inhibitor from Q32 Bio Phase 2 basket trial planned to evaluate complement

articleQ32 Bio Inc.December 1, 20254/company/q32-bio-inc/news/akebia-announces-establishment-of-rare-kidney-disease-pipeline
Akebia Announces Establishment of Rare Kidney Disease Pipeline

About this update from Q32 Bio Inc.

[{"type":"text","content":"Acquires next generation tissue-targeted C3d-Factor H fusion protein complement inhibitor from Q32 Bio Phase 2 basket trial planned to evaluate complement inhibitor in multiple rare kidney disease indications Phase 2 trial of Praliciguat, an sGC stimulator, initiated in focal segmental glomerulosclerosis (FSGS) Both trials planned to start treating subjects in 2026 CAMBRIDGE, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the establishment of its rare kidney disease pipeline. The pipeline is comprised of two core product candidates: ADX-097, a potential next generation complement inhibitor (now referred to as AKB-097) and praliciguat, a soluble guanylate cyclase (sGC) stimulator. Akebia acquired all rights to AKB-097, a tissue-targeted C3d-Factor H fusion protein complement inhibitor, from Q32 Bio Inc. (Nasdaq: QTTB) and believes AKB-097 has applicability across a wide range of complement-mediated rare kidney diseases. AKB-097 is targeted to the sites of complement activation in tissues and is not expected to result in systemic complement inhibition seen with other inhibitors. Separately, Akebia is evaluating praliciguat initially in a clinical trial in the treatment of FSGS, a rare kidney disease, and also plans to assess its use in other rare podocytopathies. “Our commitment to patients with kidney disease is supported by two pillars of our corporate strategy: first, to drive Vafseo to become standard of care in anemia due to CKD in dialysis, and second, to build and progress our kidney disease pipeline,” said John P. Butler, Chief Executive Officer of Akebia. “While our commercial and medical teams continue to build on the momentum of our Vafseo launch, we are excited to take an important step forward as a company with the establishment of our rare kidney disease development pipeline. We believe our differentiated complement inhibitor program can play a key role in addressing numerous rare kidney diseases, as can praliciguat, which we intend to initially study in FSGS. We look forward to enrolling patients in Phase 2 trials with each product candidate next year and expect to begin generating clinical data from an AKB-097 Phase 2 basket trial beginning in 2027.” About Comple...

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