Otsuka announces positive Phase III trial of sibeprenlimab

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) today announced positive top-line interim data from the ongoing Phase III clinical trial of sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults.

The US Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment of IgAN; Berger’s disease in February this year, following favorable results of the Phase II ENVISION clinical trial.

Sibeprenlimab is an investigational, anti-APRIL monoclonal antibody (A PRoliferation-Inducing Ligand) that blocks a key initiating step in the immune pathogenic cascade of IgA nephropathy by limiting Gd-IgA1 production and immune complex formation. IgA nephropathy is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients.