Biogen Idec building
Biogen has announced that it has initiated a late-stage study of felzartamab in adult kidney transplant recipients who have been diagnosed with late antibody-mediated rejection (AMR).
The phase 3 TRANSCEND trial will randomise approximately 120 patients to receive nine intravenous infusions of investigational felzartamab or placebo over six months, after which point all patients will be given Biogen’s candidate for an additional six months.
AMR occurs when the immune system recognises a transplanted organ as foreign and produces antibodies against it. Despite being a major cause of kidney transplant failure, Biogen outlined that effective treatment options for late AMR are currently limited.
Travis Murdoch, head of HI-Bio at Biogen, described the launch of the TRANSCEND trial as a “crucial milestone in the advancement of [felzartamab’s] clinical development”.
“Losing a kidney after receiving a long-awaited transplant is devastating for the patient and the donor. As we enrol [in] 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,” Murdoch said.
Felzartamab has already been shown in clinical studies to selectively deplete CD38-positive plasma cells, which Biogen said “may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies”.
Principal investigator of the study Suphamai Bunnapradist, Connie Frank Kidney Transplant Center, said: “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.”
Biogen gained access to felzartamab in July through its $1.8bn acquisition of Human Immunology Biosciences (HI-Bio), which had exclusively licensed the rights to develop and commercialise the asset across all indications in all countries and territories excluding China in 2022. The drug was originally developed by MorphoSys, which Novartis also acquired last year.
Beyond AMR, Biogen is planning to initiate phase 3 trials of felzartamab in two kidney diseases, IgA nephropathy and primary membranous nephropathy, in 2025.