Sitryx initiates Phase1 clinical trial of potential disease-modifying treatment for atopic dermatitis SYX-5219

24 March 2025

Sitryx Therapeutics, a clinical-stage biopharmaceutical company developing novel oral therapies to restore immune balance in autoimmune and inflammatory disease, has announced the initiation of its first-in-human Phase 1a clinical trial evaluating SYX-5219 for the treatment of atopic dermatitis.

This milestone follows the recent Clinical Trial Authorisation (CTA) granted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). SYX-5219 is the second program from the Sitryx portfolio to enter clinical development following commencement of a Phase 1 trial to develop SYX-1042 (itaconate mimetic) by partner Lilly in 2024.

The Phase 1a trial, initiated in the UK, is an interventional placebo-controlled study designed to assess the safety, tolerability and pharmacokinetics of SYX-5219 in healthy volunteers. It is the first of a two-part study, with the Phase 1b trial in adults with moderate to severe atopic dermatitis expected to commence later in 2025 in the UK, Europe and the US.

SYX-5219 offers first-in-class potential as an oral, disease-modifying anti-inflammatory therapy, targeting a critical enzyme that regulates cell metabolism called pyruvate kinase M2 (PKM2). Modulation of PKM2 alters B and T lymphocyte function and represents a novel therapeutic target with the potential to rebalance the immune system, normalise immune cell function and drive sustained disease remission in atopic dermatitis and other inflammatory diseases.

Atopic dermatitis is a chronic inflammatory skin disease affecting over 200 million individuals worldwide. More than five million people in the US and Europe are living with a moderate to severe form of the disease, experiencing persistent inflammation and severe itching, which significantly impacts quality of life1. Preclinical data have shown that SYX-5219 reduces inflammatory markers and enhances skin barrier repair, supporting its potential as a disease-modifying therapy.

Iain Kilty, Chief Executive Officer of Sitryx, said: “The initiation of our second Phase 1 trial is a major milestone for Sitryx, reflecting the cutting-edge science behind our pipeline of potentially transformative therapies for major autoimmune indications. By targeting PKM2, SYX-5219 has the potential to redefine the treatment paradigm for atopic dermatitis and other autoimmune diseases, marking a new phase in precision immunology. We are excited to advance SYX-5219 into the clinic and work towards delivering meaningful, lasting benefits to patients.”

Ravi Rao, Chief Medical Officer of Sitryx, said: “Atopic dermatitis remains a challenging condition with few effective oral treatment options. SYX-5219 is designed to provide a convenient once-daily oral treatment with a unique mechanism of action that directly targets metabolic imbalances driving immune dysfunction. This trial will initially provide crucial data on the safety and pharmacokinetics of SYX-5219 before investigating the clinical and biological effect on patients with atopic dermatitis, laying the groundwork for future studies aimed at developing treatments that not only manage symptoms but also aim for sustained disease remission.”

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