Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Late Antibody-Mediated Rejection (AMR) in Kidney Transplant Patients

Core Viewpoint - Biogen has initiated the Phase 3 TRANSCEND clinical study to evaluate the efficacy and safety of felzartamab in adult kidney transplant recipients with late antibody-mediated rejection (AMR) [1][2]. Company Overview - Biogen is a leading biotechnology company founded in 1978, focusing on innovative science to develop new medicines and create value for shareholders and communities [8]. - The company acquired Human Immunology Biosciences (HI-Bio) in July 2024, which holds exclusive rights to develop and commercialize felzartamab across various indications [4]. Drug Development - Felzartamab is an investigational human monoclonal antibody targeting CD38, with potential applications in various immune-mediated diseases [4]. - The Phase 3 TRANSCEND study will enroll approximately 120 kidney transplant recipients and is designed as a two-part, 52-week, double-blind, placebo-controlled trial [1][2]. - The primary endpoint of the study is the percentage of participants achieving resolution of AMR by biopsy at 6 months, with key secondary endpoints including changes in microvascular inflammation (MVI) score [2][5]. Market Context - AMR is a significant challenge in kidney transplantation, with around 23,000 patients in the U.S. affected by various forms of AMR [5]. - Current treatment options for late AMR are limited, highlighting the potential importance of felzartamab as a new therapeutic option if approved [2][7]. Future Plans - In addition to the TRANSCEND study, Biogen plans to initiate Phase 3 trials of felzartamab for IgA nephropathy and primary membranous nephropathy in 2025 [3]. - MorphoSys, the original developer of felzartamab, will receive a one-time milestone payment of $35 million from Biogen as part of the trial initiation [3].