Eli Lilly's IL-2R agonist application for clinical application

Today, the official website of CDE showed that the clinical application of Eli Lilly IL-2R agonist LY3471851 injection (NKTR-358) was officially accepted by the State Food and Drug Administration.

IL-2 production disorder and regulatory T cell (Treg) dysfunction are thought to be related to the occurrence of a variety of autoimmune diseases.

NKTR-358 is a First-in-Class IL-2R agonist developed by Nektar Company.

Preclinical studies have shown that NKTR-358 has low affinity for IL-2Rβγ and high affinity for IL-2Rαβγ, and can selectively restore Treg levels without affecting the function of traditional T cells (Tcon).

Experimental results of non-human primate animal models show that Treg cells can be selectively expanded

In June 2020, Eli Lilly and Nektar jointly announced the phase Ib clinical study data of NKTR-358 for patients with moderate to severe systemic lupus erythematosus (SLE).

The results of the study showed that the safety of NKTR-358 was well tolerated, and the Treg cells in patients showed a significant, selective and dose-dependent increase, and they were maintained after multiple administrations.

The increase of Tregs in SLE patients in the NKTR-358 24μg/kg dose group was similar to the increase observed in the 28μg/kg dose group in healthy volunteers.

And NKTR-358 did not cause changes in the levels of traditional T cells and NK cells in patients as a whole.

After multiple administrations, the level of Tregs in SLE patients was similar to that of healthy volunteers.

Eli Lilly is currently carrying out a phase II clinical study of NKTR-358 for the treatment of SLE, and two other phase Ib studies for psoriasis and atopic dermatitis are also underway.