NKTR

NKTR-358

Systemic Lupus Erythematosus

Stage (next event)

Expected Date

Phase 1b

TBD

Catalyst Info & Data Links

TITLE: NKTR-385 in patients with Systemic Lupus Erythematosus

  • NCT03556007: A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE)



WHAT IS THE CATALYST EVENT?

  • TBD



WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • TBD



PRIOR DATA

Mechanism of Action

MECHANISM OF ACTION

  • Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. NKTR-358 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance. Nektar entered into a strategic collaboration with Lilly in 2017 to develop and commercialize NKTR-358.

  • NKTR-358 is being developed by Lilly as a self-administered injection for a number of autoimmune and inflammatory diseases. A Phase 2 study of NKTR-358 is underway in adults with systemic lupus erythematosus (ISLAND-SLE) (NCT04433585). The investigational therapy is also currently being evaluated in two separate Phase 1b studies in patients with atopic dermatitis (NCT04081350) and psoriasis (NCT04119557).

MARKET

  • The Lupus Foundation of America estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus.

  • Lupus strikes mostly women of childbearing age. However, men, children, and teenagers develop lupus, too.

  • Ninety percent (90%) of people living with lupus are women. Most people with lupus develop the disease between the ages of 15-44.[2]

  • People with lupus can experience significant symptoms, such as pain, extreme fatigue, hair loss, cognitive issues, and physical impairments that affect every facet of their lives. Many suffer from cardiovascular disease, strokes, disfiguring rashes, and painful joints. For others, there may be no visible symptoms.

  • Our best estimate based on available data on incidence is 16,000 new cases per year. The Centers for Disease Control and Prevention (CDC) are currently gathering updated data for all ethnic sub-populations in the US, so we anticipate this number will change. The fact remains that lupus is a devastating and life-changing disease that currently has no cure.

  • Learn more at the Lupus Foundation of America

Updated by HC

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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