Zai Lab antibody shows sustained biomarker suppression in phase 1 trial
By Jon CuthbertKey points
- Zai Lab Limited (NASDAQ:ZLAB; HKEX:9688) reported preliminary Phase 1 results showing that a single dose of ZL-1503 achieved at least 90% inhibition of an inflammation-related biomarker for 12 weeks.
- The experimental antibody demonstrated a 40–50-day serum half-life, dose-proportional exposure and no serious adverse events or detectable anti-drug antibodies.
- Zai Lab expects results from the multiple-dose patient cohort in the first half of 2027 as it advances development of ZL-1503 for moderate-to-severe atopic dermatitis.
Zai Lab Limited (NASDAQ:ZLAB) reported preliminary Phase 1 results showing that a single dose of its experimental antibody ZL-1503 achieved at least 90% inhibition of an inflammation-related biomarker for 12 weeks in healthy volunteers.
The global Phase 1/1b study evaluated single doses ranging from 50 mg to 1,000 mg, with doses of 200 mg or higher producing sustained inhibition of IL-13-stimulated phosphorylated STAT6 (pSTAT6), a biomarker associated with atopic dermatitis.
"These first-in-human findings reinforce the potential of ZL-1503 as a differentiated, first-in-class treatment option for patients with atopic dermatitis," said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab.
The antibody demonstrated a serum half-life of approximately 40–50 days and dose-proportional exposure, with no serious adverse events, dose-limiting toxicities or detectable anti-drug antibodies reported among participants receiving the treatment.
ZL-1503 is an investigational bispecific antibody designed to target IL-13 and IL-31 receptor alpha pathways, which are involved in skin inflammation and itching associated with atopic dermatitis.
Zai Lab expects initial results from the multiple-ascending-dose patient cohort in the first half of 2027 and has completed enrollment in a separate intravenous-to-subcutaneous bridging study, with initial results also expected in 2027.
