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Akebia Announces Establishment of Rare Kidney Disease Pipeline
Globenewswireยท 2025-12-01 12:00
Core Insights - Akebia Therapeutics has established a rare kidney disease pipeline, focusing on two main product candidates: AKB-097, a complement inhibitor, and praliciguat, an sGC stimulator [2][3] - The company plans to initiate Phase 2 clinical trials for both AKB-097 and praliciguat in 2026, targeting multiple rare kidney disease indications [1][3] Group 1: Product Candidates - AKB-097 is a tissue-targeted C3d-Factor H fusion protein complement inhibitor acquired from Q32 Bio, expected to address a range of complement-mediated rare kidney diseases [2][5] - Praliciguat is an oral sGC stimulator, with initial clinical trials focusing on focal segmental glomerulosclerosis (FSGS), a rare kidney disease [2][8] Group 2: Clinical Trials - The Phase 2 basket trial for AKB-097 is set to begin in the second half of 2026, with initial data expected in 2027 [6][3] - The Phase 2 trial for praliciguat will enroll up to 60 patients in the U.S., with the primary efficacy endpoint being the change in urine protein-to-creatinine ratio over 24 weeks [10][11] Group 3: Financial Aspects - Akebia paid an upfront fee of $7 million to Q32 Bio for the acquisition of AKB-097, with additional payments tied to development milestones and royalties on net sales [7]