China-based Lynk Pharmaceuticals Co., Ltd has announced that its Phase II clinical study for LNK01001 in atopic dermatitis (AD) has yielded positive major results. The study, a randomized, double-blinded, placebo-controlled, multi-center trial, enrolled 150 patients and included high-dose and low-dose groups of LNK01001 alongside a placebo group.
Study Design and Primary Efficacy Endpoint
The primary efficacy endpoint of the study was the percentage change in the Eczema Area and Severity Index (EASI) score from baseline at week 12. Preliminary data indicates that at 12 weeks, patients in both the high and low dose groups of LNK01001 experienced significant improvement in their condition, with a statistically significant difference in EASI scores compared to the placebo group, thus reaching the primary endpoint.
EASI-75 and IGA Response Rates
Furthermore, the proportion of subjects in the high and low dose groups of LNK01001 who achieved EASI-75 (a decrease of ≥ 75% from baseline in EASI score) and overall investigator’s global assessment (IGA) response was significantly higher than that of the placebo group.
Rapid Itching Relief and Safety Profile
LNK01001 also showed a rapid effect on improving itching, with significant improvement in the itching index within 24 hours post-administration compared to the placebo group. In terms of safety, both the high and low dose groups of LNK01001 exhibited good overall tolerability, with the incidence of side effects and serious adverse events at level 2 or above comparable to the placebo group. No major cardiovascular adverse events (MACE), venous thromboembolism (VTE), malignant tumors, or serious infections were reported.
Ongoing Clinical Studies for LNK01001
LNK01001, a JAK1 inhibitor, is currently undergoing clinical studies for other autoimmune diseases, including rheumatoid arthritis and ankylosing spondylitis, indicating its potential in treating a range of conditions.-Fineline Info & Tech
