Biogen(US:BIIB) Globenewswire·2025-06-30 11:30Core Viewpoint - Biogen has initiated a Phase 3 clinical study, PROMINENT, to evaluate the efficacy and safety of felzartamab in treating primary membranous nephropathy (PMN), a severe kidney disease with no approved treatments [1][4]. Company Overview - Biogen is a leading biotechnology company founded in 1978, focused on innovative science to develop new medicines and create value for shareholders and communities [10]. - The company has a commitment to advancing treatment options for patients with kidney diseases, as evidenced by the launch of multiple Phase 3 trials for felzartamab in 2025 [3][5]. Drug Information - Felzartamab is an investigational anti-CD38 monoclonal antibody that selectively depletes CD38+ plasma cells, which are implicated in various immune-mediated diseases [2][6]. - The drug targets patients with PMN, where up to 80% have autoantibodies against PLA2R, and aims to provide a novel treatment option in a field lacking approved therapies [2][9]. Clinical Study Details - The PROMINENT study will enroll approximately 180 adults with PMN and is expected to read out in 2029 [1]. - The trial is designed as a 104-week, randomized, open-label study comparing felzartamab to tacrolimus, with the primary endpoint being the percentage of participants achieving complete remission of proteinuria at week 104 [3][4]. - Key secondary endpoints include the impact on serum anti-PLA2R antibodies and patient-reported outcomes [3]. Previous Research - Felzartamab has shown promising results in earlier Phase 2 studies, with significant reductions in aPLA2R titers and improvements in proteinuria and serum albumin levels observed [4][6]. - The majority of treatment-emergent adverse events reported were mild to moderate, primarily infusion-related reactions [4]. Market Context - PMN is a rare immune-mediated kidney disease with an estimated prevalence of approximately 36,000 patients in the U.S., highlighting the unmet medical need in this area [6][9].