Nektar Therapeutics has started dosing patients in Phase I clinical trial of NKTR-358 for treatment of various auto-immune diseases and inflammatory disorders.

Designed to rectify the underlying immune system dysfunction associated with immune disorders, NKTR-358 selectively induces growth and activation of regulatory T cells in the body to restore self-tolerance mechanisms.  

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The dose-finding Phase I trial will assess single-ascending doses of the product.

Nektar Therapeutics biology vice-president Jonathan Zalevsky said: "Data from non-human primate studies show that NKTR-358 drives proliferation and increased functional activity of Regulatory T cells (Tregs).

"Suboptimal Treg numbers and their lack of activity underlie many autoimmune diseases, including lupus, Crohn's disease, psoriasis, rheumatoid arthritis and multiple sclerosis.

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"As the first potential medicine to restore appropriate Treg levels and function, NKTR-358 could address a critical unmet need for patients with serious and debilitating immune disorders."

"As the first potential medicine to restore appropriate Treg levels and function, NKTR-358 could address a critical unmet need for patients with serious and debilitating immune disorders."

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The trial will involve measurement of observed changes and functional activity of regulatory T cells, as well as pharmacokinetics and safety in 50 healthy participants.

The primary objective of the trial is to determine a range of dose levels that could be developed in further clinical trials.

In the second half of this year, Nektar plans to further evaluate NKTR-358 in a multiple-ascending dose clinical trial for treating ystemic lupus erythematosus (SLE) patients.

Being developed as a self-administered injection for multiple auto-immune disorders, NKTR-358 optimally targets the interleukin-2 (IL-2) receptor complex.