LNK01004, a skin-restricted, soft pan-Janus kinase (JAK) inhibitor for the treatment of atopic dermatitis (AD), showed efficacy and safety in a Phase 2 study, according to top-line results.
This randomized, double-blind, vehicle-controlled Phase 2 study evaluated the efficacy and safety of topical LNK01004 ointment (0.3% and 1.0%) in adult patients with moderate-to-severe AD. A total of 75 patients were enrolled and randomized in a 1:1:1 ratio to receive LNK01004 0.3%, LNK01004 1.0%, or vehicle ointment twice daily (BID) for eight weeks. Eligible patients had a Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 or 4 and Body Surface Area (BSA) involvement between 5% and 35%.
After eight weeks of treatment, both LNK01004 dose groups achieved higher Eczema Area and Severity Index (EASI)-75 response rates than the vehicle group, with more pronounced benefits in patients with higher baseline BSA. Among patients with BSA ≥10%, the EASI-75 response rates for the 0.3%, 1.0%, and vehicle groups were 61.1%, 46.2%, and 20%, respectively. The vIGA-AD (score 0/1 with ≥2-point improvement) response rates were 44.4%, 38.5%, and 10%, respectively. In patients with BSA ≥20%, both LNK01004 groups showed even greater clinical improvements.
Safety results showed low systemic exposure following topical administration, with mean Cmax values of 0.06ng/mL and 0.15ng/mL for the 0.3% and 1.0% groups, respectively, hundreds of times lower than the human whole-blood IC50. LNK01004 demonstrated good overall tolerability at both doses, consistent with findings from earlier studies. All treatment-related adverse events (TRAEs) were mild or moderate (Grade 1–2), and no treatment-related serious adverse events (SAEs) were observed.
“These findings highlight LNK01004 as a promising topical JAK inhibitor and underscore its potential clinical value in dermatologic indications,” says Henry Wu, PhD, Chief Development Officer of Lynk Pharmaceuticals, in a news release.
