- In March 2024, Chinook Therapeutics, Inc. announced promising clinical results from its ongoing Phase II AFFINITY trial for zigakibart (BION-1301), a novel anti-APRIL monoclonal antibody therapy developed for treating primary FSGS. The data indicated substantial reductions in proteinuria with favorable safety and tolerability, reinforcing zigakibart’s potential as a first-in-class targeted therapy. This development marks a significant stride in addressing the unmet clinical needs of FSGS patients through precision medicine
- In February 2024, Travere Therapeutics, Inc. submitted a supplemental New Drug Application (sNDA) to the U.S. FDA for sparsentan, an investigational dual endothelin angiotensin receptor antagonist (DEARA), for the treatment of FSGS. Sparsentan previously received accelerated approval for IgA nephropathy and has demonstrated encouraging efficacy in reducing proteinuria in FSGS patients. The filing signifies a key milestone for expanding the therapeutic landscape in rare kidney diseases
- In December 2023, Calliditas Therapeutics AB launched a collaborative study with academic institutions across Europe to evaluate Nefecon in patients with overlapping renal pathologies, including FSGS. The study is designed to understand the impact of targeted-release corticosteroid therapy on complex glomerular conditions. This research reflects the growing focus on adaptive treatment strategies tailored to diverse glomerulopathies
- In October 2023, Vertex Pharmaceuticals Incorporated initiated Phase I trials of a novel investigational compound from its renal pipeline, aimed at addressing APOL1-mediated kidney diseases including FSGS. The candidate, developed using Vertex’s precision targeting approach, represents a next-generation solution to tackle genetic drivers of FSGS, particularly prevalent in individuals of African descent. This signals increased industry momentum toward genotype-guided FSGS treatment
- In August 2023, Goldfinch Bio, Inc. announced the continuation of its GFB-887 clinical development, a TRPC5 ion channel inhibitor, in collaboration with nephrology networks across North America and Asia. Early-phase results demonstrated encouraging renal protective effects in patients with FSGS. The advancement of GFB-887 reinforces Goldfinch Bio’s commitment to mechanistic, biomarker-driven innovation in chronic kidney disorders such as FSGS
