Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as "Lynk Pharmaceuticals"), a clinical-stage innovative drug development company, announced positive results from its Phase 1b clinical study of LNK01004, a skin restricted, soft pan-JAK inhibitor, for the treatment of atopic dermatitis.

The study is a randomized, double-blind, placebo-controlled, multicenter clinical trial aimed at evaluating the safety, tolerability, and pharmacokinetic characteristics of topical applications of LNK01004 in adult subjects with mild to moderate atopic dermatitis. The trial results showed that LNK01004 ointment demonstrated good safety and tolerability for up to 4 weeks of topical application; no measurable skin irritation was observed, and no patient withdrew from the study. Among the results, the 1.0% dose group of LNK01004 showed the most positive efficacy outcomes, with EASI-75, IGA 0/1, and PP-NRS4 response rates of 63%, 50%, and 75%, respectively, after 4 weeks of treatment (compared to 17%, 17%, and 33%, respectively, in the placebo group). The positive results from this study provide a solid foundation for the smooth progression of subsequent clinical trials.

Atopic dermatitis is a chronic, recurrent, inflammatory skin disease characterized by repeated flare-ups and a prolonged course that can severely affect patients' quality of life. LNK01004 ointment is a topically applied, skin-restricted JAK inhibitor with extremely low systemic exposure. In both healthy subjects and patients with atopic dermatitis, the maximum detectable drug concentration in the blood is approximately 0.1 ng/mL (0.1 nanogram/mL), which is far below the JAK human whole blood IC50. This minimizes potential safety issues due to systemic drug exposure, offering patients a potentially safer and more effective treatment option with first-in-class potential.

Dr. Henry Wu, Chief Development Officer of Lynk Pharmaceuticals, stated, "Atopic dermatitis has a profound impact on patients' quality of life. LNK01004 ointment has shown good safety and preliminary efficacy in the exploratory clinical trials. We will continue to accelerate the clinical development of this program, hoping that this innovative therapy will bring relief to patients suffering from atopic dermatitis and possibly other autoimmune indications."

"We are pleased to have achieved positive results in the Phase 1b proof-of-concept (POC) clinical trial of LNK01004 for the treatment of atopic dermatitis. As a third-generation, skin-restricted JAK inhibitor, LNK01004 can effectively treat diseases like atopic dermatitis, which severely affect quality of life of patients. LNK01004 almost has no exposure in the bloodstream, it significantly reduces the side effects associated with other systemic immunosuppressants, whether they are biologics or other oral small molecules, offering a first-in-class potential. In clinical trials, no signature safety signals associated with other JAK inhibitors have been observed," said Dr. Zhao-Kui (ZK) Wan, Chairman and CEO of Lynk Pharmaceuticals. "LNK01004 can effectively inhibit multiple inflammatory cytokines, it has the potential to treat various immune diseases including atopic dermatitis, psoriasis, alopecia areata, etc. We look forward to further validating the efficacy and safety of LNK01004 in subsequent clinical studies."