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.
"Data from non-human primate studies show that NKTR-358 drives proliferation and increased functional activity of Regulatory T cells (Tregs), said Jonathan Zalevsky, Ph.D., vice president of biology at Nektar Therapeutics. Suboptimal Treg numbers and their lack of activity underlie many autoimmune diseases, including lupus, Crohn's disease, psoriasis, rheumatoid arthritis and multiple sclerosis."

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.