Sitryx Therapeutics announced it has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application for SYX-5219, enabling the initiation of a Phase 1b trial in adults with moderate to severe atopic dermatitis. The clinical-stage biopharmaceutical company expects to begin the trial in Q1 2026.
Novel Mechanism Targets Metabolic Pathway
SYX-5219 represents a first-in-class, oral, disease-modifying, anti-inflammatory therapy targeting pyruvate kinase M2 (PKM2), a critical enzyme that regulates cell metabolism. By modulating PKM2, the drug alters T lymphocyte and mast cell function, creating a differentiated broad, anti-itch and pro-barrier repair profile with the potential to drive sustained disease remission in atopic dermatitis and other autoimmune conditions.
The safety, tolerability and pharmacokinetics of SYX-5219 are currently being evaluated in healthy volunteers in an ongoing Phase 1a trial in the United Kingdom, following a Clinical Trial Authorisation by the Medicines and Healthcare products Regulatory Agency.
Preclinical Evidence Supports Disease-Modifying Potential
Preclinical studies have demonstrated that SYX-5219 reduces inflammatory markers, known drivers of itch, and enhances skin barrier repair, supporting its potential as a disease-modifying therapy. These findings provide the scientific foundation for advancing the compound into patient populations.
Addressing Significant Unmet Medical Need
According to Ravi Rao, Chief Medical Officer of Sitryx, atopic dermatitis affects over 200 million people worldwide, with the persistent inflammation and severe itching associated with the disease significantly impacting patients' quality of life. "SYX-5219 offers a novel oral approach with the potential to deliver durable disease remission, and the upcoming Phase 1b study will provide important insights into its clinical and biological effects in patients, laying a solid foundation for future studies in atopic dermatitis and other conditions," Rao stated.
Clinical Development Milestone
Iain Kilty, Chief Executive Officer of Sitryx, emphasized the significance of the regulatory clearance: "The FDA's clearance of our IND application represents a pivotal milestone in the clinical development of SYX-5219, bringing us closer to delivering a much-needed treatment option for patients living with atopic dermatitis and other autoimmune conditions. We look forward to initiating this trial and generating data that will guide the next stage of development, providing life-changing benefits to patients."
Company Background and Funding
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, Eli Lilly and Company, and GSK. The company is headquartered in Oxford, UK with additional presence in Boston, MA, and focuses on developing novel oral therapies to restore immune balance in autoimmune and inflammatory diseases.
