Sitryx Therapeutics, a clinical-stage biopharmaceutical company developing novel oral therapies to restore immune balance in autoimmune and inflammatory diseases, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SYX-5219. This approval supports the initiation of a Phase 1b trial in adults with moderate to severe atopic dermatitis (AD) in the United States, expected to start in Q1 2026.
About SYX-5219
SYX-5219 is a first-in-class, oral, disease-modifying, anti-inflammatory therapy that targets pyruvate kinase M2 (PKM2), a key enzyme regulating cell metabolism. By modulating PKM2, SYX-5219:
- Alters T lymphocyte and mast cell function
- Offers a broad anti-itch effect
- Supports skin barrier repair
- Has potential to drive sustained disease remission in atopic dermatitis and other autoimmune conditions
Preclinical studies have demonstrated that SYX-5219 reduces inflammatory markers and enhances barrier repair, supporting its potential as a disease-modifying therapy.
Current Clinical Development
- Phase 1a trial: Evaluating safety, tolerability, and pharmacokinetics in healthy volunteers in the UK, under approval from the MHRA (Medicines and Healthcare products Regulatory Agency)
- Phase 1b trial: Will assess clinical and biological effects in adults with moderate to severe atopic dermatitis in the US
“The US FDA’s clearance of our IND application represents a pivotal milestone in the clinical development of SYX-5219. We look forward to generating data that will guide the next stage of development and provide life-changing benefits to patients.”
- Iain Kilty, CEO of Sitryx.
“Atopic dermatitis affects over 200 million people worldwide. SYX-5219 offers a novel oral approach with the potential for durable disease remission, and the Phase 1b study will provide critical insights into its effects in patients.”
- Ravi Rao, CMO of Sitryx.
