An Expert Comment

According to Brian Kotzin, M.D., Senior Vice President, Clinical Development and NKTR-358 Program Lead at Nektar Therapeutics, 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. Dr. Kotzin stated that  “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….”  

NKTR-358 in Healthy Volunteers

A first-in-human Phase 1a single-ascending dose study of NKTR-358 in healthy volunteers was presented at the Annual European Congress of Rheumatology (EULAR). NKTR-358 was found to be well-tolerated and demonstrated a marked and selective dose-dependent expansion of T regulatory cells with no measurable effect on conventional CD4+ and CD8+ T cells.

• Additional data from the single-ascending dose study will be presented at the 2019 Annual Meeting of the American College of Rheumatology next month.  
• About 6.6 million adults report moderate-to-severe symptoms of Atopic dermatitis (AD)1.  
• According to the World Psoriasis Day consortium, 125 million people worldwide—2 to 3 percent of the total population—have psoriasis.

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 NKTR-358 

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.

Prohost Observations

It is always good news when biopharmaceutical firms add into their pipelines new products that treat immune diseases that have yet to find satisfactory treatments.  The good news becomes excellent news when the added drugs make scientific sense and treat several diseases. NKTR-358 is currently in clinical trials for three conditions comprising atopic dermatitis, psoriasis and systemic lupus erythematosus.

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