Biogen Inc. Initiates Phase 3 Study of Felzartamab for the Treatment of Primary Membranous Nephropathy

Published: 2025-06-30 15:21:27 ET BIIB

Published on 06/30/2025 at 15:21

Biogen Inc. announced the initiation of dosing in the global clinical study, PROMINENT. The Phase 3 study will evaluate the efficacy and safety of the investigational drug felzartamab compared to tacrolimus in adults diagnosed with primary membranous nephropathy (PMN). PROMINENT is designed to enroll approximately 180 adults with PMN and expected to readout in29.

PMN is a severe antibody-mediated disease of the kidney that is a leading cause of nephrotic syndrome and carries a significant risk of kidney failure. Felzartamab is an anti-CD38 antibody that has been shown in clinical studies to selectively deplete CD38+ cells, including plasma cells, the source of autoantibodies that mistakenly attack the body's own tissues in a range of immune-mediated diseases. Importantly for felzartamab, it is estimated that up to 80% of PMN patients have autoantibodies against PLA2R (aPLA2R) generated by CD38-expressing plasma cells.

Currently, there are no approved treatments for PMN and the standard of care includes treatments ranging from immunosuppressants to chemotherapy. There are no approved treatments for PM N and the current standard of care includes treatments rangingfrom immunosuppressants tootherapy. Even with these strategies, approximately one third of patients do not achieve remission.