Antibody-mediated rejection is a significant cause of kidney transplant failure. Credit: sasirin pamai / Shutterstock.
US-based biotechnology company Biogen has begun dosing in the Phase III TRANSCEND trial to assess felzartamab in adult kidney transplant recipients with late antibody-mediated rejection (AMR).
The randomised, double-blind trial aims to enrol roughly 120 subjects and will asses felzartamab’s safety and efficacy against those of a placebo.
In Part A of the 52-week trial, subjects will be given nine intravenous infusions of either felzartamab or placebo over a six-month period, with the drug’s safety and efficacy due to be evaluated after 24 weeks.
The TRANSCEND study’s primary endpoint is the proportion of subjects who show resolution of AMR by biopsy at the end of the six months.
Its secondary endpoints include changes in microvascular inflammation (MVI) score and the percentage of subjects achieving zero for this score.
Part B of the trial will involve an open-label period in which all subjects will receive the drug for an additional 6-12 months to assess safety, tolerability and long-term activity.
Biogen HI-Bio head Travis Murdoch said: “Building upon the promising results from the Phase II 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.
“As we enrol in this pivotal Phase III 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.”
Felzartamab is a human monoclonal antibody that targets the cluster of differentiation 38 (CD38) and is tailored to minimise pathogenic antibody-producing plasma cells and natural killer (NK) cell activity.
The drug was originally developed by MorphoSys, a German biopharmaceutical company owned by Novartis.
In September 2024, Biogen reported that the Phase II/III DEVOTE trial of high-dose Spinraza met its primary endpoint in a cohort of infants with spinal muscular atrophy.
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