Biogen has started dosing in the Phase III PROMINENT trial, assessing the efficacy and safety of the felzartamab drug in the adult population with primary membranous nephropathy (PMN), a severe antibody-mediated kidney disease.
The 104-week, open-label, randomised, global, multicentre trial aims to enrol around 180 PMN subjects and the readout is anticipated in 2029.
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It will compare the safety and efficacy of the drug against tacrolimus in moderate- to-high-risk subjects, including newly diagnosed and relapsed ones.
The primary goal is the percentage of subjects achieving complete remission of proteinuria at week 104.
Participants will be stratified based on PLA2R levels and the trial will assess both anti-PLA2R autoantibody positive and negative subjects.
Key secondary goals will assess the drug’s impact on serum anti-PLA2R antibodies and outcomes reported by patients.
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By GlobalDataBiogen West Coast Hub head Travis Murdoch said: “We are encouraged by the opportunity to advance a Phase III study for primary membranous nephropathy, a condition that carries a significant risk of kidney failure.
“This is the third Phase III trial of felzartamab launched by Biogen this year, underscoring our ongoing commitment to developing potential novel treatment options for patients living with kidney disease.”
The drug was previously assessed in two Phase II trials, M-PLACE and NewPLACE, which enrolled aPLA2R-positive PMN subjects.
In M-PLACE’s final analysis, minimisations in aPLA2R titers were noted in most subjects as early as one week, with responses in most of them found at the six-month period during the end-of-treatment.
Additionally, proteinuria and serum albumin level improvements were found with the drug’s administration. Most treatment emergent adverse events (TEAEs) were mild to moderate.
Alongside PROMINENT, the company has initiated two other Phase III trials of the drug: TRANSCEND and PREVAIL, targeting different kidney conditions.
The human monoclonal antibody felzartamab targets cluster of differentiation 38 (CD38) and was developed originally by MorphoSys, a Novartis company.
Human Immunology Biosciences (HI-Bio) holds the exclusive licence to develop and commercialise the drug. HI-Bio was acquired by Biogen in July 2024.
Recently, Biogen started dosing in the Phase III BRAVE trial to assess omaveloxolone in children aged between two to 16 years with Friedreich ataxia (FA).
