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First-in-Class Oral PKM2 Modulator SYX-5219 Phase 1a Trial Data to be Presented at SID 2026

13th May 2026

  • First-in-human healthy volunteers trial showed SYX-5219 was safe and well tolerated
  • Systemic immunomodulation of type 2 inflammation demonstrated with reduction in serum CCL17/TARC
  • Phase 1b trial in adults with severe atopic dermatitis ongoing

Oxford, UK and Boston, MA – 13 May 2026 – Sitryx Therapeutics (“the Company”), a clinical-stage biopharmaceutical company developing novel oral therapies to restore immune balance in autoimmune and inflammatory disease, will share positive findings from a Phase 1a trial of its lead clinical program, SYX-5219, at the 83rd Society for Investigative Dermatology (SID) Annual Meeting, taking place in Chicago from today until 16 May.

In its late-breaking poster presentation, the Company will share the first clinical data generated for its first-in-class, oral pyruvate kinase M2 (PKM2) modulator, which has the potential to drive sustained disease remission in atopic dermatitis, the most common chronic inflammatory skin disease affecting over 200 million patients worldwide.

The first-in-human, randomized, double-blind, placebo-controlled Phase 1a trial evaluated the safety, tolerability, and pharmacokinetics of SYX-5219 in 96 healthy adult participants across single-ascending-dose and 14-day multiple-ascending dose exposure periods.

SYX-5219 was safe and well tolerated across all doses, with no serious, unexpected or severe adverse events or treatment-related lab abnormalities. At steady state, exposures were within a model-predicted range associated with efficacy in preclinical dermatitis models. Exposure-dependent target engagement was observed, with pyruvate kinase activity reaching ≥EC95 at doses ≥30 mg, once daily.

Furthermore, evidence of systemic immunomodulation of type 2 inflammation biomarkers was demonstrated in the trial with a reduction in serum CCL17/thymus and activation-regulated chemokine (TARC) levels at doses ≥30 mg, twice daily. This activity against an established biomarker of type 2 inflammation, which has been shown to correlate with disease activity and treatment response in atopic dermatitis across multiple clinical programs, is the first clinical evidence supporting SYX-5219’s potential to influence disease-relevant immune pathways.

These clinical data, combining safety, pharmacokinetics, target engagement and biomarker reduction, further underpin our belief in the potential of SYX-5219 as a differentiated, disease-modifying oral treatment

Ravi Rao, Chief Medical Officer of Sitryx

Ravi Rao, Chief Medical Officer of Sitryx, commented: “These clinical data, combining safety, pharmacokinetics, target engagement and biomarker reduction, further underpin our belief in the potential of SYX-5219 as a differentiated, disease-modifying oral treatment targeting multiple aspects of atopic dermatitis pathology. With our Phase 1b trial well underway in adult patients, 2026 will be an important year to validate our novel immunometabolic approach with SYX-5219.”

POSTER DETAILS

Poster title: A novel oral pyruvate kinase M2 (PKM2) modulator for atopic dermatitis (SYX-5219) demonstrates favorable safety, pharmacokinetics, target engagement and evidence of type 2 immunomodulation: results from a first-in-human Phase 1a study.

Abstract number: LB1150

ABOUT SYX-5219

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 with the potential to normalise immune cell function and drive sustained disease remission in atopic dermatitis (eczema).

A Phase 1b clinical trial evaluating SYX-5219 in adults with moderate to severe atopic dermatitis commenced in January 2026 and will investigate the safety, tolerability and initial efficacy of SYX-5219 in up to 45 adult patients in the United States and Europe. The Company expects to receive data from the trial by year end. A KLH antigen-challenge study in healthy volunteers is also underway, to assess early immune response signals.

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For more information about Sitryx please contact:

ICR Healthcare

Mary-Jane Elliott, David Daley, Evi Useh

+44 (0)20 3709 5700

Sitryx@icrhealthcare.com

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.

Established with seed funding from SV Health Investors, Sitryx has an international syndicate of specialist investors including SV Health Investors, Sofinnova Partners, Oxford Science Enterprises, Longwood Fund, Eli Lilly and Company, and GSK.

Sitryx is headquartered in Oxford, UK with additional presence in Boston, MA. For more information, please visit www.sitryx.com.