Clinical Trials

Date: 2017-03-27

Type of information: Treatment of the first patient

phase: 1

Announcement: treatment of the first patient

Company: Nektar Therapeutics (USA - CA)

Product: NKTR-358

Action mechanism:

immunotherapy product. NKTR-358 works by optimally targeting the interleukin-2 receptor complex in order to stimulate proliferation and activation of regulatory T cells. By increasing the number of regulatory T cells, the pathogenic auto-reactive T cells can be controlled and the proper balance of effector and regulatory T cells can be achieved to restore the body's self-tolerance mechanisms.
In preclinical studies, NKTR-358 has demonstrated that it could suppress antigen-driven inflammation in a model of cutaneous hypersensitivity. NKTR-358 has also shown that it reduces markers of progression in a mouse model of systemic lupus erythematosus.
NKTR-358 is being developed as a once or twice-monthly self-administered injection for a number of auto-immune diseases.

Disease:

Therapeutic area: Autoimmune diseases - Inflammatory diseases

Country:

Trial details:

Latest news:

• On March 27, 2017, Nektar Therapeutics announced that it has begun dosing in a Phase 1 clinical study evaluating NKTR-358, which is being developed to treat a wide range of auto-immune diseases and inflammatory disorders. The Phase 1 study will evaluate single-ascending doses of NKTR-358 in approximately 50 healthy subjects. The Phase 1 study is a dose-finding trial for NKTR-358 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.
"NKTR-358 has the potential to be a first-in-class key resolution therapeutic in immunology," "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, " said Jonathan Zalevsky, Ph.D., vice president of biology at Nektar Therapeutics.