Business
First-in-Human Data Presented from Phase 1a Study of NKTR-358, a Novel T Regulatory Cell Stimulator, at Annual European Congress of Rheumatology
MADRID and SAN FRANCISCO, June 13, 2019 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced the results of the first-in-human Phase 1a study
About this update from Nektar Therapeutics
[{"type":"text","content":"MADRID and SAN FRANCISCO, June 13, 2019 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced the results of the first-in-human Phase 1a study evaluating single-ascending doses of NKTR-358, a first-in-class T regulatory cell stimulator in clinical development for the treatment of autoimmune and other chronic inflammatory conditions. \nThe data, which were presented during an oral session at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, show that NKTR-358 was safe and well-tolerated and led to a marked and selective dose-dependent expansion of T regulatory cells with no measurable effect on conventional CD4+ and CD8+ T cells (Tcons). NKTR-358 was discovered by Nektar and is being co-developed and commercialized in partnership with Eli Lilly and Company. \nNKTR-358 is designed to correct the underlying immune system imbalance in people with autoimmune conditions, which are associated with reduced numbers and impaired function of powerful inhibitory immune cells, known as T regulatory (Treg) cells. NKTR-358 works by targeting the interleukin (IL-2) alpha-beta-gamma receptor complex in the body to stimulate proliferation of Treg cells and their suppressive functional activity. \n\"The data presented at EULAR 2019 demonstrate its meaningful and targeted effect of selective proliferation of Treg cells,\" said Brian Kotzin, M.D., Senior Vice President, Clinical Development and NKTR-358 Program Lead at Nektar Therapeutics. \"This first-in-human single ascending dose study also demonstrated a favorable safety and tolerability profile. NKTR-358 is designed to help the body regulate and control pathogenic auto-reactive T cells and restore normal self-tolerance mechanisms and these data provide strong support to study NKTR-358 as a potential treatment for a range of autoimmune and inflammatory diseases.\" \nThe double-blind, single-ascending dose Phase 1a study evaluated 100 healthy volunteers who received subcutaneous doses of NKTR-358 ranging from 0.3 to 28 µg/kg. Subjects were followed for 50 days following administration. \nKey highlights from today's data presentation include: \nNKTR-358 was safe and well tolerated in this first-in human study Preliminary data suggest dose-proportional pharmacokinetics for NKTR-358 and prolonged exposure with a half-life of 8-9 days NKTR-358 resulted in marked and se...