Biogen launches phase 3 trial of felzartamab in kidney transplant patients

Biogen has embarked on a significant clinical study, focusing on its investigational drug, felzartamab, aimed at treating late antibody-mediated rejection (AMR) in kidney transplant recipients. The pharmaceutical giant has initiated a phase 3 trial, named TRANSCEND, which will include around 120 adult patients who have experienced this type of rejection after transplantation.

In this study, participants will be randomly assigned to receive either felzartamab or a placebo through nine intravenous infusions over a six-month period. Following this initial phase, all participants will be transitioned to receive felzartamab exclusively for an additional six months. This trial design underscores Biogen's commitment to exploring the efficacy of felzartamab in offering a viable treatment for late-stage AMR, a condition characterized by the immune system's production of antibodies against a transplanted organ. This immune response is a leading cause of kidney transplant failure, yet current treatment options are quite limited.

Travis Murdoch, who oversees HI-Bio at Biogen, emphasized the significance of this trial in the broader context of felzartamab’s clinical journey. Murdoch expressed hope that this drug could become a pioneering treatment option for patients living with late AMR, marking a pivotal advancement in the field. He highlighted the grave impact of losing a transplanted kidney on both the recipient and the donor, reinforcing the urgency and importance of developing effective treatments.

Felzartamab's mechanism of action involves the selective depletion of CD38-positive plasma cells. This approach has been shown in earlier clinical studies to hold potential in improving clinical outcomes across various diseases driven by pathogenic antibodies. The principal investigator of the TRANSCEND study, Suphamai Bunnapradist, from the Connie Frank Kidney Transplant Center, voiced optimism about felzartamab's potential as a disease-modifying therapy, citing encouraging phase 2 results as a foundation for this belief.

Biogen acquired felzartamab through its acquisition of Human Immunology Biosciences (HI-Bio) for $1.8 billion in July. HI-Bio had previously secured exclusive rights to the drug's development and commercialization globally, excluding China, from its original developer, MorphoSys. Notably, MorphoSys was acquired by Novartis last year, adding another layer to the drug's developmental history.

Looking beyond its current focus on AMR, Biogen has ambitious plans for felzartamab's application in other kidney-related conditions. The company intends to launch phase 3 trials targeting IgA nephropathy and primary membranous nephropathy in 2025. These future trials underscore Biogen's broader strategy to position felzartamab as a versatile therapeutic option across a spectrum of kidney diseases.

Overall, Biogen's initiation of the TRANSCEND trial marks a strategic move in the landscape of kidney transplant medicine, where the need for innovative treatments remains critical. The development of felzartamab, if successful, could herald a new chapter not only for kidney transplant patients facing late AMR but also for the broader field of kidney disease treatment. The ongoing collaboration with medical and patient communities worldwide highlights Biogen's dedication to addressing these complex medical challenges with cutting-edge science and innovative solutions.