Lynk Pharmaceuticals Announces Key Phase II Clinical Results of LNK01004 for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis

HANGZHOU, China and SHANGHAI and BOSTON, Nov. 19, 2025 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as "Lynk Pharmaceuticals"), a clinical-stage innovative drug development company, today announced key results from its Phase II clinical trial of LNK01004, a skin restricted, soft pan-JAK inhibitor, for the treatment of atopic dermatitis (AD).

This randomized, double-blind, vehicle-controlled Phase II 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 8 weeks. Eligible patients had a vIGA-AD score of 3 or 4 and BSA involvement between 5% and 35%.

Efficacy results demonstrated that after 8 weeks of treatment, both LNK01004 dose groups achieved higher 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, further supporting its potential as a treatment for moderate-to-severe AD.

Safety results showed low systemic exposure following topical administration, with mean Cmax values of 0.06 ng/mL and 0.15 ng/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.

Dr. Henry Wu, Chief Development Officer of Lynk Pharmaceuticals, said: "The Phase II results for LNK01004 demonstrated encouraging efficacy and favorable safety in patients with moderate-to-severe atopic dermatitis, particularly in those with larger affected areas or more severe disease. These findings highlight LNK01004 as a promising topical JAK inhibitor and underscore its potential clinical value in dermatologic indications."

"Current treatment options for moderate-to-severe atopic dermatitis often rely on systemic therapies," said Dr. Zhao-Kui (ZK) Wan, Chairman and CEO of Lynk Pharmaceuticals. "LNK01004, as a topical formulation, no systemic immunosuppression–related adverse reactions were observed in clinical studies, demonstrating good safety and compliance, as well as improvement in patients' quality of life. We will continue advancing its clinical development in AD and other indications to bring more innovative treatment options to patients with dermatological diseases worldwide."

About Lynk Pharmaceuticals:

Lynk Pharmaceuticals, a clinical stage company, was founded by senior drug R&D experts and executives from Pfizer, Merck, and Johnson & Johnson. Lynk Pharmaceuticals is dedicated to the discovery and development of innovative drugs for the treatment of immune and inflammatory diseases. Driven by a higher goal, Lynk Pharmaceuticals aims to be a market leader to address unmet medical demands by the development of innovative therapies. We thrive to provide differentiated innovative therapies to benefit patients globally. To date, Lynk Pharmaceuticals has independently developed several innovative new drug candidates and successfully completed a number of clinical studies. For more information about Lynk Pharmaceuticals, please visit: https://www.lynkpharma.com.

SOURCE Lynk Pharmaceuticals Co., Ltd.