On March 11, 2025, Biogen Inc. announced the initiation of dosing in the global Phase 3 TRANSCEND clinical study. This pivotal trial will evaluate the efficacy and safety of the investigational drug felzartamab compared to placebo in adult kidney transplant recipients diagnosed with late antibody-mediated rejection (AMR), a major cause of kidney transplant failure.
The TRANSCEND study is designed to enroll approximately 120 kidney transplant recipients with late AMR. Participants will be randomized to receive nine intravenous infusions of felzartamab or placebo over six months, with the primary endpoint being the percentage of participants achieving resolution by biopsy of AMR at six months. Key secondary endpoints include changes in microvascular inflammation (MVI) score, which strongly correlates with reduced kidney allograft survival rates.
Felzartamab, an anti-CD38 monoclonal antibody, is designed to reduce pathogenic antibody-producing plasma cells and NK cell activity, addressing key drivers of MVI and AMR. Building on promising Phase 2 results, the launch of TRANSCEND is a crucial milestone in its clinical development. As part of this initiation, MorphoSys AG will earn a one-time milestone payment of $35 million from Biogen, highlighting the financial implications of advancing this program.
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