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.
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.
"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."
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.
