News Nektar Therapeutics Starts Phase 1 Trial of NKTR-358 for Autoimmune Diseases Nektar Therapeutics Starts Phase 1 Trial of NKTR-358 for Autoimmune Diseases by James Frederick, PA-C, MMSc | April 6, 2017 Share this article: Share article via email Copy article link Nektar TherapeuticsĀ has started a Phase 1 clinical trial of its biologic therapy NKTR-358 forĀ inflammatory disorders and autoimmune diseases like multiple sclerosis. NKTR-358 is a first-in-class regulatory T-cell stimulator designed to correct the immune system dysfunction associated with these disorders. ItĀ targets regulatory T-cells, or Tregs. Other immunosuppressant therapies suppress the entire immune system. By stimulating the growth and activation ofĀ Tregs selectively, NKTR-358 decreases the side effects of immunosuppressive therapy. Treg dysfunction has been implicated in many autoimmune disorders, including multiple sclerosis, Crohnās disease, lupus, and rheumatoid arthritis, Nektar said. Primate studies have shown that NKTR-358 increases Treg functioning. In particular, it restores the bodyās ability to distinguish between its own molecules and invaders. In addition, NKTR-358 reduced markers of disease progression in a mouse model of systemic lupus erythematosus (SLE), Nektar said. “NKTR-358 has the potential to be a first-in-class key resolution therapeutic in immunology,” Jonathan Zalevsky, PhD, vice president of biology at Nektar, said in a press release. “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.”Ā Zalevsky added. TheĀ Phase 1 clinical trial that is under way will assessĀ single ascending doses of NKTR-358 in aroundĀ 50 healthy participants. The goal is toĀ define a range of doses that can be used in new clinical trials. The drug’s safety andĀ pharmacokinetics — or how it behaves in the body — will also be accessed. A second trial evaluating NKTR-358 in patients withĀ SLEĀ is planned for the second half of 2017. NKTR-358 is being developed asĀ a once- or twice-monthly self-administered injection, Nektar said. Estimates are that more than 23 million Americans have an autoimmune disease, which represents almost 8 percent of the population. More than 80 types of autoimmune diseases have been identified, and their prevalence is rising. Print This Page About the Author James Frederick, PA-C, MMSc James Frederick is a practicing Physician Associate (PA-C, MMSc) who studied at Yale University. He also has a bachelorās degree in creative writing and English Literature from the University of Colorado. He specializes in writing medical content that is approachable, readable and enjoyable. He has a strong background in research, physiology, pharmacotherapy, emergency medicine and critical care medicine. In his free time he enjoys spending my time camping and traveling with his wife and dog. Tags autoimmune disease, clinical trial, immunotherapy, regulatory T-cells, Tregs
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