Nektar Therapeutics Announces Initiation of Two Clinical Studies of Novel T Regulatory Cell Stimulator NKTR-358 (LY3471851) in Patients with Psoriasis and Atopic Dermatitis

SAN FRANCISCO, CA, USA I October 7, 2019 I Nektar Therapeutics (NASDAQ: NKTR) today announced the initiation of two Phase 1b studies of NKTR-358 (LY3471851*), a novel T regulatory (Treg) cell stimulator, one in patients with psoriasis and one in patients with atopic dermatitis. NKTR-358 is designed to treat autoimmune and inflammatory conditions by correcting the immune system imbalance that results from reduced numbers and impaired function of immune regulating Treg cells. NKTR-358 works by targeting the interleukin-2 receptor complex to stimulate the proliferation and suppressive functional activity of Treg cells. Nektar entered into a strategic collaboration with Eli Lilly and Company in 2017 to develop and commercialize NKTR-358. The two Phase 1b studies are Lilly-sponsored studies.

"Dysfunctions in Treg cell biology are implicated in the breakdown of immune self-tolerance, which is one of the underlying mechanisms involved in autoimmune and inflammatory diseases such as lupus, atopic dermatitis and psoriasis," said Brian Kotzin, M.D., Senior Vice President, Clinical Development and NKTR-358 Program Lead at Nektar Therapeutics. "NKTR-358 has demonstrated that it can drive expansion of Tregs, which we believe could help to regulate and control pathogenic T cells and restore normal self-tolerance mechanisms. We are excited to start these clinical studies to explore NKTR-358 for the treatment of psoriasis and atopic dermatitis, two common inflammatory diseases."

Earlier this year, Nektar presented initial results of a first-in-human Phase 1a single-ascending dose study of NKTR-358 in healthy volunteers at the Annual European Congress of Rheumatology (EULAR). The data 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. Nektar plans to present additional data from the single-ascending dose study at the 2019 Annual Meeting of the American College of Rheumatology in November 2019. 

Atopic dermatitis (AD), also known as eczema, is a chronic, inflammatory skin disease which results in widespread rashes and patches of itchy skin, which can become thickened, cracked, raw or leak fluid when scratched. About 6.6 million adults report moderate-to-severe symptoms of AD1. AD is commonly associated with an individual or family history of asthma, hay fever, food allergy and/or other allergic diseases.

Psoriasis is an immune-mediated skin disease that causes raised, red, scaly patches to appear on the skin typically affecting the outsides of the elbows, knees or scalp. According to the World Psoriasis Day consortium, 125 million people worldwide—2 to 3 percent of the total population—have psoriasis2.

NKTR-358 is also being evaluated in a double-blind, randomized, placebo-controlled Phase 1b study in adults with systemic lupus erythematosus (SLE). The study will evaluate the safety, tolerability, pharmacokinetics and immunological effects of multiple ascending doses of NKTR-358 in approximately 50 adults with SLE. For more information, please visit clinicaltrials.gov and search NCT03556007.

About the Phase 1b Study in Psoriasis

The Phase 1b study is a 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.

About the Phase 1b Study in Atopic Dermatitis

The Phase 1b study is a 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.

About NKTR-358 (LY3471851)

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 resolution therapeutic that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It targets the interleukin-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 may act to bring the immune system back into balance.

NKTR-358 is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases.

About Nektar Therapeutics

Nektar Therapeutics is a research-based, development-stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, autoimmune disease and chronic pain. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

SOURCE: Nektar Therapeutics

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