Study Medication (Atacicept)
What is the study medication?
The study medication is called atacicept. It is a subcutaneous injection given once weekly.
The study medication is investigational, which means it can only be used in research studies. It has not been approved by regulatory authorities like the U.S. Food and Drug Administration (FDA) or European Medications Agency (EMA) as an IgA Nephropathy (IgAN) medication.
How does the study medication work?
The study medication is designed to target IgA Nephropathy (IgAN) at its source. IgAN occurs when your immune system increasingly releases an abnormal protein called galactose deficient IgA (or Gd-IgA1) that is a target for autoantibodies. It then clusters and builds up in the kidneys, causing inflammation. By helping to control this immune response, the study medication may reduce the buildup of immune complexes and prevent damage to the kidneys. An early clinical study with atacicept showed potential benefit for IgAN patients, including the reduction of Gd-IgA1 that is believed to be the source of the disease. However, more clinical data is needed to validate the effect of the study medication.
Have other people used the study medication?
Yes. Over 1,000 people with various autoimmune disease have received at least one dose of atacicept in clinical studies both within and outside the U.S.