Positive Topline Data Seen in Phase II Trial of LNK01001 in AD

After 12 weeks of treatment, patients in both the high and low dose groups showed significant improvement, with a statistically significant difference in the percentage change from baseline in EASI score compared to the placebo group.

Lynk Pharmaceuticals Co., Ltd.’s LNK01001 performed well in a Phase II clinical trial for the treatment of atopic dermatitis (AD), according to positive topline data from the Company.

LNK01001 is a highly selective JAK1 inhibitor that blocks JAK1 without crossing over onto other JAK subtypes.

The study was a randomized, double-blind, placebo-controlled, multicenter Phase II trial conducted in adult patients (aged 18-75) with moderate-to-severe AD who had previously received inadequate response to topical treatment for AD or had previously received other systemic treatment for AD. 

The study, which was led by Professor Jianzhong Zhang, Director of the Dermatology Department at Peking University People's Hospital, included 150 patients. The patients were randomly divided into three trial groups at a ratio of 1:1:1, namely LNK01001 high-dose, low-dose, and placebo groups. The primary efficacy endpoint of the study was the percentage change from baseline in the eczema area and severity index (EASI) score at Week 12.

Preliminary data showed that after 12 weeks of treatment, patients in both the high and low dose groups showed significant improvement, with a statistically significant difference in the percentage change from baseline in EASI score compared to the placebo group, achieving the primary endpoint. Additionally, the proportion of responders achieving EASI-75 (≥75% improvement from baseline in EASI score) and Investigator's Global Assessment (IGA) response were significantly higher in both high and low dose groups of LNK01001 compared to the placebo group. Improvement of pruritus is an important indicator of quality of life for patients with atopic dermatitis, and the results of the trial showed that LNK01001 had a rapid onset of improvement in pruritus, with both the high and low dose groups of LNK01001 showing significantly better improvement in pruritus indices than the placebo group at 24 hours after dosing.

In terms of safety, both high- and low-dose groups of LNK01001 demonstrated good overall tolerability, with comparable rates of CTC grade 2+ treatment-emergent adverse events (TEAE) and serious adverse events (SAE) compared to the placebo group. No major adverse cardiovascular events (MACE), venous thromboembolism (VTE), malignancies, or severe infections were reported.

“The results of this study suggest that LNK01001 has the potential to provide clinical benefits to adult patients with moderate to severe AD,” says Dr. Zhang. “We will continue to conduct further research and look forward to validating the efficacy and safety of LNK01001 in Phase III clinical trials to benefit more patients."

Dr. Henry Wu, Chief Development Officer of Lynk Pharmaceuticals, adds, "We are preparing to submit an application for the End of Phase II (EOP2)/Pre-Phase III meeting to advance the clinical development of this compound and strive to benefit more patients as soon as possible."