RESEARCH FOCUS: Autoimmune Disease
Autoimmune disease affects more than 23 million Americans – nearly eight percent of the U.S. population – and the prevalence is continuing to rise.1,2 There are more than 80 known types of autoimmune diseases, including lupus, Crohn’s disease, psoriasis and rheumatoid arthritis.1 Autoimmune diseases cause the immune system to mistakenly attack healthy cells in a person’s body.1 Current systemic treatments for autoimmune disease, including corticosteroids and anti-TNF agents, suppress the immune system broadly and come with severe side effects.
NKTR-358 is designed to correct the underlying immune system imbalance in the body which occurs in patients with auto-immune disease. The breakdown of mechanisms assuring recognition of self and non-self is what underlies all autoimmune diseases. A failure of the body's self-tolerance mechanisms is known to result from pathogenic auto reactive T lymphocytes. By increasing the number of T regulatory cells (which are specific immune cells in the body that modulate the immune system and prevent auto-immune disease by maintaining self-tolerance), these pathogenic auto reactive T cells can be reduced and the proper balance of effector and regulatory T cells can be achieved to restore the body's self-tolerance mechanisms. There is consistent evidence that suboptimal T regulatory cell numbers and their lack of activity, play a significant role in a myriad of autoimmune diseases.
In February 2017, Nektar submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NKTR-358. Clinical trials are planned for NKTR-358 in patients with systemic lupus erythematous (SLE) and other potential immune disease indications.