NKTR-358 is an investigative therapy being evaluated by Nektar Therapeutics for inflammatory and autoimmune diseases such as lupus, a chronic autoimmune disease that can affect any part of the body, especially the joints, skin, and internal organs.

How NKTR-358 works

It works by stimulating the proliferation and activation of a special type of cells called regulatory T-cells, which are responsible for regulating the body’s immune response. NKTR-358 specifically targets the interleukin-2 (IL-2) receptor complex that is present on the surface of these cells.

In several autoimmune disorders, the level of regulatory T-cells is low and they are inactive. NKTR-358 works by stimulating the growth and activation of regulatory T-cells. The compound restores the levels of regulatory T-cells and corrects the imbalance that occurs in various autoimmune disorders.

The working mechanism is different from that of immunosuppressant drugs used in treating autoimmune diseases. According to Nektar, unlike immunosuppressant medicines, NKTR-358 does not treat the symptoms of autoimmune diseases by inhibiting the entire immune system. Instead, it selectively stimulates the growth and activation of regulatory T-cells in the body and restores the body’s self-tolerance mechanisms. This working mechanism of NKTR-358 is believed to treat autoimmune diseases by generating fewer side-effects compared to immunosuppressant drugs.

NKTR-358 in clinical trials

Nektar tested it in mouse and nonhuman primate models. The results reported at the World Congress on Inflammation in July 2017 suggest that NKTR-358 can successfully increase the number and suppressive function of regulatory T-cells. The compound was also shown to reduce inflammation in mice for seven to 10 days and in nonhuman primates for more than two weeks.

Nektar Therapeutics recently initiated a Phase 1 clinical study to test it in healthy volunteers as a potential treatment for a wide range of autoimmune diseases and inflammatory disorders. The main goal of the study is to establish an optimal dose, as well as evaluate the safety and pharmacokinetics — how the drug is processed in the body— of NKTR-358.

The company is also planning a multiple-ascending dose trial investigating NKTR-358 in patients with systemic lupus erythematosus (SLE). This trial is expected to start in 2017.


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