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New Clinical Data Presented from Phase 1b Study of NKTR-358, a Novel T Regulatory Cell Stimulator, at 2020 American College of Rheumatology (ACR) Congress
SAN FRANCISCO, Nov. 4, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced the presentation of additional clinical data from the Phase 1b study
About this update from Nektar Therapeutics
[{"type":"text","content":" SAN FRANCISCO, Nov. 4, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced the presentation of additional clinical data from the Phase 1b study evaluating multiple ascending doses of NKTR-358, a first-in-class T regulatory cell stimulator, currently in development for the treatment of a range of autoimmune disorders, including systemic lupus erythematosus (SLE).\nInitial data presented earlier this year at the European Congress of Rheumatology (EULAR) 2020 showed that NKTR-358 was safe and well tolerated in patients with mild-to-moderate SLE and led to a marked and selective, dose-dependent expansion of regulatory T cells (Tregs) that was maintained over multiple administrations. The ACR 2020 presentation includes additional clinical and pharmacodynamic data from this Phase 1b study including key biomarkers of Treg function and assessment of disease characteristics in mild to moderate SLE patients. \n\"In our data presented at ACR 2020, we were excited to see that NKTR-358 demonstrated a dose-dependent reduction in CLASI-A composite clinical scores in patients with mild-to-moderate SLE after only 3 treatment cycles. Complementing these clinical results, we also observed dose-dependent biomarker changes associated with Treg activation including increases in Treg functional markers, changes in DNA methylation of the FoxP3 locus, and increased expression of Treg functional genes,\" said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar. \"These results support further investigation of NKTR-358 in patients with auto-immune disorders and inflammatory diseases, including the Phase 2 study underway in lupus patients being conducted by our partner Eli Lilly & Co.\"\nThe randomized, double-blind, multiple-ascending dose Phase 1b data from the study being presented at 2020 ACR evaluated safety, pharmacokinetics (PK) and pharmacodynamics (PD) in a total of 48 SLE patients across 4 separate ascending dose cohorts who received subcutaneous Q2W doses of NKTR-358 (n=9 per cohort) or placebo (n=3 per cohort). Subjects were treated for a total of six weeks.\nKey conclusions from today's data presentation at ACR 2020 include:\nNKTR-358 was safe and well tolerated with a similar safety profile for single and repeat doses in patients with mild-to-moderate SLE as was observed in healthy volunteers from a prior Ph...