Sitryx 公布 SYX-5219 治疗特应性皮炎 Phase 1b 阳性数据

Results support advancement into phase 2 trials

Sitryx Therapeutics has announced positive topline phase 1b results for SYX-5219, a first-in-class oral PKM2 modulator being developed for moderate to severe atopic dermatitis.

The findings provide the first clinical evidence that targeting PKM2 to modulate immune cell metabolism can deliver meaningful benefit for patients with atopic dermatitis. SYX-5219 was safe and well tolerated over the six-week treatment period, with pharmacokinetic and target engagement findings consistent with earlier healthy volunteer studies.

Iain Kilty said: “These positive results are an exciting milestone for Sitryx and a testament to the excellent execution by our team and clinical partners.”

He added: “We have provided the first human validation for a differentiated oral therapy, demonstrating activity across multiple clinical endpoints and biomarkers in patients with atopic dermatitis.”

The randomised, double-blind, placebo-controlled phase 1b trial enrolled 35 adults across sites in the United States and Europe. Patients received SYX-5219 or placebo for six weeks, followed by a 14-day off-treatment period. Differences from placebo were observed from Day 8, increasing throughout the dosing period. SYX-5219 met exploratory efficacy targets for skin disease severity, measured by EASI, and itch, measured by PP-NRS.

At six weeks, the placebo-adjusted change in total EASI score was approximately 28%, while the placebo-adjusted difference in PP-NRS itch score was around 48%. An increasing number of patients achieved at least a one-point improvement in vIGA, supported by reductions in several atopic dermatitis biomarkers.

Biomarker decreases included CCL-17/TARC and CCL-11/eotaxin, which significantly correlated with improvements in disease activity. Additional exploratory findings, including reductions in IL-13 and IgE, support investigation of PKM2 modulation in asthma and other inflammatory diseases.