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Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Late Antibody-Mediated Rejection (AMR) in Kidney Transplant Patients
Global Phase 3 TRANSCEND study will evaluate the efficacy and safety of felzartamab, as compared to placebo, in adults with late AMRAMR is a leading cause of
About this update from Biogen Inc.
[{"type":"text","content":"Global Phase 3 TRANSCEND study will evaluate the efficacy and safety of felzartamab, as compared to placebo, in adults with late AMRAMR is a leading cause of kidney transplant loss, with approximately ~23k patients living with all forms of AMR in the U.S1Felzartamab, with demonstrated proof of concept in multiple immune-mediated diseases, represents a key asset in Biogen’s late-stage immunology portfolio CAMBRIDGE, Mass., March 11, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced the initiation of dosing in the global clinical study, TRANSCEND. The Phase 3 study 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). TRANSCEND is designed to enroll approximately 120 kidney transplant recipients with late AMR. “Building upon the promising results from the Phase 2 study, which demonstrated felzartamab’s first-in-class potential, the launch of the TRANSCEND trial is a crucial milestone in the advancement of its clinical development,” said Travis Murdoch, Head of HI-Bio at Biogen. “Losing a kidney after receiving a long-awaited transplant is devastating for the patient and the donor. As we enroll this pivotal Phase 3 trial, we look forward to working in collaboration with medical and patient communities worldwide with the hope of bringing felzartamab forward as potentially the first meaningful treatment option, if approved, for people living with late AMR.” “Antibody-mediated rejection remains a significant challenge in kidney transplantation, with limited safer and effective treatment options currently available. With the potential to be disease-modifying based on the encouraging results observed in the Phase 2 study, I believe felzartamab could be an important new therapeutic treatment option for patients with late AMR,” said Suphamai Bunnapradist, M.D., principal investigator of the study and Professor of Clinical Medicine, Director of Research at Connie Frank Kidney Transplant Center, University of California, Los Angeles. \"I am pleased to see Biogen enroll the first patient in the Phase 3 TRANSCEND study of felzartamab in AMR and look forward to the trial’s continued enrollment.” TRANSCEND is a two-part, 52-week, double-blind, placebo-controlled, multicenter, randomized Phase 3 c...