Positive Interim Results From Study of IgA Nephropathy Treatment

Obi Umeh, MD, VP, Franchise Global Program Leader at Takeda, discusses positive interim results from study of mezagitamab for IgA nephropathy.

IgA nephropathy is a kidney disorder that occurs when IgA accumulates in the kidneys. In the early stages, IgA nephropathy has no symptoms. The first sign of this condition may be blood in the urine. If left untreated, end-stage kidney disease may develop. In most instances, the cause of this condition is unknown; however, certain disorders have been linked with IgA nephropathy, such as cirrhosis of the liver, celiac disease, and HIV infection.

Mezagitamab (TAK-079) is a fully human IgG1 monoclonal antibody that depletes CD38 expressing cells. The phase 3-enabling proof-of-concept study demonstrated the favorable safety profile and tolerability of mezagitamab. Additionally, rapid and sustained reductions from baseline in serum IgA, Gd-IgA1, and IgG levels were observed at week 36, as well as a 54.9% mean reduction in proteinuria.

Based on these results, a phase 3 clinical trial is in development.