Sitryx initiates Phase 1 clinical trial of potential disease-modifying treatment for atopic dermatitis SYX-5219
- SYX-5219 is a first-in-class oral PKM2 modulator designed to drive sustained disease remission
- Novel mechanism of action suggests SYX-5219 has potential across broad range of inflammatory diseases
Oxford, UK – 20 March 2025 – Sitryx Therapeutics (“the Company”), a clinical-stage biopharmaceutical company developing novel oral therapies to restore immune balance in autoimmune and inflammatory disease, today announces 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, commented: “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, added: “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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For more information about Sitryx please contact:
ICR Healthcare
Mary-Jane Elliott, David Daley, Sue Stuart
+44 (0)20 3709 5700
[email protected]
About SYX-5219
SYX-5219 is a novel, first-in-class oral therapy targeting pyruvate kinase M2 (PKM2), a key regulator of immune cell metabolism. By shifting PKM2 into its anti-inflammatory state, SYX-5219 is designed to rebalance immune function, reduce inflammation, and restore skin barrier integrity in atopic dermatitis patients. Unlike existing biologic and JAK inhibitor therapies, SYX-5219 offers a convenient, once-daily oral treatment that aims to provide long-term disease control with an improved safety profile.
About Sitryx
Sitryx is a clinical-stage biopharmaceutical company developing novel oral therapies to restore immune balance in autoimmune and inflammatory disease. The Company has a broad pipeline of novel small molecule candidates targeting major autoimmune indications with high unmet need. Its lead candidate, SYX-5219, is a potentially first-in-class PKM2 modulator in development for atopic dermatitis as a once-daily oral therapy with future development potential across multiple autoimmune diseases.
In 2020, Sitryx formed an exclusive global licensing and research collaboration with Eli Lilly and Company, with the first program, SYX-1042 (itaconate mimetic), now in-house at Lilly and in clinical development, with the commencement of a Phase 1 trial in January 2024.
Established in 2018 with seed funding from SV Health Investors, Sitryx has raised $85 million to date from an international syndicate of specialist investors including SV Health Investors, Sofinnova Partners, Oxford Science Enterprises, Longwood Fund, Lilly and GSK.
Sitryx is headquartered in Oxford, UK. For more information, please visit www.sitryx.com.
