Sitryx Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for SYX-5219, to support the initiation of a Phase 1b trial in adults with moderate-to-severe atopic dermatitis in the United States. The company expects to initiate the trial in Q1 2026.

SYX-5219 is 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, SYX-5219 alters T lymphocyte and mast cell function, representing 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 (CTA) by the Medicines and Healthcare products Regulatory Agency (MHRA). Preclinical studies have shown that SYX-5219 reduces inflammatory markers, known drivers of itch and enhances skin barrier repair, supporting its potential as a disease-modifying therapy.

Iain Kilty, CEO, Sitryx, commented, “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.”

Atopic dermatitis affects over 200 million people worldwide ... SYX-5219 offers a novel oral approach with the potential to deliver durable disease remission.

Ravi Rao, Chief Medical Officer, Sitryx, added, “Atopic dermatitis affects more than 200 million people worldwide and the persistent inflammation and severe itching associated with the disease significantly impacts the quality of life of patients. 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.”