NKTR-358

About NKTR-358

Autoimmune disease affects more than 23 million Americans – nearly eight percent of the U.S. population – and the prevalence is continuing to rise.1,2 There are more than 80 known types of autoimmune diseases, including lupus, Crohn’s disease, psoriasis and rheumatoid arthritis.1 Autoimmune diseases cause the immune system to mistakenly attack healthy cells in a person’s body.1 Current systemic treatments for autoimmune disease, including corticosteroids and anti-TNF agents, suppress the immune system broadly and come with severe side effects.

NKTR-358 is a novel regulatory T cell stimulator that addresses an underlying immune system imbalance in patients with many of these autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 can act to bring the immune system back into balance. This could lead to a profound clinical impact and healthy organ function in autoimmune conditions.

NKTR-358 is being developed as a once or twice-monthly self-administered injection for a number of autoimmune diseases. In July 2017, Nektar entered into a strategic collaboration with Lilly to develop and commercialize NKTR-358.

In June 2019, initial results of a first-in-human Phase 1a single-ascending dose study of NKTR-358 in healthy volunteers showed that NKTR-358 was 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. (EULAR 2019)

In April 2018, Nektar initiated a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics and immunological effects of multiple ascending doses of NKTR-358 in approximately 50 patients with systemic lupus erythematosus (SLE). The study will also evaluate the effects of NKTR-358 on disease activity in SLE patients.

In October 2019, Lilly initiated two Phase 1b studies of NKTR-358, one in patients with psoriasis and one in patients with atopic dermatitis. Each of studies will evaluate the safety, tolerability and pharmacokinetics of NKTR-358 in patients with plaque psoriasis or atopic dermatitis. Exploratory objectives include assessment of disease activity and biomarkers.

 

About the Phase 2, Randomized, Double-Blind Study of NKTR-358 (LY3471851) in Adults with Systemic Lupus Erythematosus (ISLAND-SLE)

The Phase 2 trial, sponsored by Lilly, is a double-blind, randomized, study designed to compare the efficacy of three separate doses of NKTR-358, administered once every two weeks, to placebo. The primary endpoint of the study is the percent of patients achieving at least a 4-point reduction in the SLEDAI-2K scale after 24 weeks of treatment. Secondary endpoints include the percent of patients who achieve an SRI -4 response, BILAG-based BICLA response, and a level of low disease as defined by the Lupus Low Disease Activity State (LLDAS). For more information, please visit clinicaltrials.gov and search NCT04433585.

About the Phase 1b Study of NKTR-358 in Patients with Systemic Lupus Erythematosus (SLE)

The Phase 1b study is a Nektar-sponsored, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and immunological effects of multiple ascending doses of NKTR-358 in approximately 50 patients with SLE. The study will also evaluate the effects of NKTR-358 on disease activity in SLE patients. For more information, please visit clinicaltrials.gov and search NCT03556007.

About the Phase 1b Study of NKTR-358 in Patients with Psoriasis

The Phase 1b study is a Lilly-sponsored, double-blind, randomized, placebo-controlled multiple-dose study of NKTR-358 and will evaluate the safety, tolerability and pharmacokinetics of NKTR-358 in approximately 40 adults with plaque psoriasis. Exploratory objectives include assessment of disease activity and biomarkers. For more information, please visit clinicaltrials.gov and search NCT04119557.

About the Phase 1b Study of NKTR-358 in Patients with Atopic Dermatitis

The Phase 1b study is a Lilly-sponsored double-blind, randomized, placebo-controlled multiple-dose study of NKTR-358 and will evaluate the safety, tolerability and pharmacokinetics of NKTR-358 in approximately 40 adults with atopic dermatitis. Exploratory objectives include assessment of disease activity and biomarkers. For additional information visit clinicaltrials.gov and search NCT04081350.

References

1.    The American Autoimmune Related Diseases Association. Autoimmune Statistics.

2.    Johns Hopkins University. Autoimmune Disease Research Center.