Biogen has announced that it has initiated a phase 3 study of investigational felzartamab in adults with primary membranous nephropathy (PMN), a severe antibody-mediated kidney disease.
The 104-week PROMINENT trial, expected to readout in 2029, will randomise approximately 180 patients with moderate- to -high-risk PMN to receive either felzartamab or tacrolimus.
It will enrol both newly diagnosed and relapsed patients, and will compare the efficacy and safety of the two drugs in achieving complete remission of protein in the urine (proteinuria).
Approximately 36,000 people in the US are affected by PMN, which carries a significant risk of kidney failure and currently has no specifically approved treatments.
The condition is a leading cause of nephrotic syndrome, which often presents with very severe swelling and fatigue related to high-grade proteinuria. Despite treatments ranging from immunosuppressants to chemotherapy, approximately one third of patients do not achieve remission.
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”.
Travis Murdoch, head of the Biogen West Coast Hub, said the company is “encouraged by the opportunity to advance a phase 3 study for PMN, a condition that carries a significant risk of kidney failure”.
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 PMN, Biogen has recently initiated two phase 3 studies of felzartamab in IgA nephropathy, and kidney transplant recipients who have been diagnosed with late antibody-mediated rejection.
Principal investigator for the PROMINENT trial, Mohamed El-Shahawy, said: “Felzartamab’s mechanism of action designed to deplete the cells that produce the pathogenic antibodies is exciting news for patients that are waiting for potential meaningful new treatment options.
“I’m grateful that Biogen is advancing research in this rare kidney disease and am eager to see the continued progress in the study’s enrolment.”