Nektar Therapeutics has started dosing patients in a Phase Ib clinical trial designed to investigate NKTR-358 as a treatment for patients with systemic lupus erythematosus (SLE).
The double-blind, randomised, placebo-controlled trial will analyse the safety, tolerability, pharmacokinetics and immunological effects of multiple ascending doses of NKTR-358 in around 50 SLE patients.
The trial will also examine the effects of NKTR-358 on disease activity in the patients.
NKTR-358 is a regulatory T cell stimulator, which is designed to selectively stimulate the proliferation and activation of regulatory T cells (Tregs) in the body in order to restore the body’s self-tolerance mechanisms.
In July last year, Nektar signed a strategic collaboration with Eli Lilly and Company to develop and commercialise NKTR-358 in various autoimmune conditions.
Nektar Therapeutics Clinical Development senior vice-president and NKTR-358 programme lead Brian Kotzin said: “NKTR-358 has the potential to address the immune system imbalance that underlies autoimmune diseases such as lupus by driving the expansion and functional activity of Tregs to restore immune homeostasis in the body.”
SLE is a chronic autoimmune disease that can impact the joints, skin, brain, lungs, kidneys, and blood vessels.
It can also cause extensive inflammation and tissue damage in the affected organs.
According to The Lupus Foundation of America, 1.5 million Americans and at least five million people worldwide are estimated to have a form of lupus.
SLE is estimated to account for 70% of all cases of lupus.