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]

Core Insights - Akebia Therapeutics is set to present data on Vafseo (vadadustat) at the American Society of Nephrology Kidney Week 2025, highlighting ongoing real-world studies and insights into its clinical benefits and dosing [1][2][3] Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [5] - Vafseo (vadadustat) is a once-daily oral medication approved for treating anemia due to chronic kidney disease (CKD) in adults on dialysis for at least three months, and it is approved in 37 countries [6][7] Clinical Studies and Presentations - Dr. Glenn M. Chertow from Stanford University will present a win odds analysis of all-cause mortality and hospitalization from the INNO2VATE trials, part of the Phase 3 clinical development program for vadadustat [2][4] - Four posters will be presented at ASN Kidney Week, focusing on dosing recommendations and ongoing real-world evidence studies, including the VOICE and VOCAL trials [2][4] Research and Development Focus - The company emphasizes the importance of generating, evaluating, and sharing data to support healthcare providers in making informed treatment decisions regarding Vafseo [3] - Akebia is actively engaged with the nephrology community to identify potential additional clinical benefits of Vafseo through various real-world evidence studies [3]

Core Insights - Akebia Therapeutics has published significant data regarding Vafseo (vadadustat) in the Journal of the American Society of Nephrology, focusing on its safety and efficacy in treating anemia related to chronic kidney disease (CKD) [1][2][4] Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company dedicated to improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [5] - The company aims to advance the understanding and treatment of kidney diseases through high-impact research [4] Product Information - Vafseo (vadadustat) is a once-daily oral medication approved by the U.S. FDA in March 2024 for treating anemia due to CKD in adults on dialysis for at least three months, and it has been available in the U.S. since January 2025 [3][6] - Vafseo functions as a hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulating the production of erythropoietin to manage anemia [6] Clinical Trial Insights - The global phase 3 clinical trials for vadadustat were open-label, randomized, and noninferiority trials comparing its safety and efficacy to darbepoetin alfa in adult patients with CKD-related anemia [2] - In the U.S. patient subgroup with dialysis-dependent CKD, the safety and efficacy of vadadustat were found to be similar to darbepoetin alfa, while in non-dialysis-dependent CKD patients, vadadustat showed a higher risk for major adverse cardiovascular events (MACE) outside the U.S. [2] Research Publication - The analyses published in JASN reflect the importance of geographic-specific data in understanding treatment outcomes for CKD-related anemia, highlighting how regional differences can affect clinical trial results [4]