RESEARCH FOCUS: Autoimmune Disease


Phase 1

About NKTR-358

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.

A Phase 1 dose-finding study for NKTR-358 is underway and will measure observed changes and functional activity of regulatory T cells. The objective of the trial is to establish a range of dose levels that could be advanced in further clinical trials. The Phase 1 study will also evaluate pharmacokinetics and safety. A multiple-ascending dose trial evaluating NKTR-358 in patients with systemic lupus erythematosus (SLE) is planned for the second half of 2017.

1The American Autoimmune Related Diseases Association. Autoimmune Statistics.

2Johns Hopkins University. Autoimmune Disease Research Center.