Lynk Pharmaceuticals Initiates Pivotal Phase III Trial for Groundbreaking Atopic Dermatitis Treatment

22 March 2024 | Friday | News

First patient dosed in landmark study of LNK01001, a promising JAK1 inhibitor, by Lynk Pharmaceuticals in China, marking a significant step forward in Atopic Dermatitis care.

Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as "Lynk Pharmaceuticals"), a clinical-stage innovative drug development company, announced that it has dosed the first patient with Atopic Dermatitis (AD) in a Phase Ⅲ clinical trial of its highly selective JAK1 inhibitor LNK01001.

This clinical study is a randomized, double-blind, placebo-controlled Phase Ⅲ clinical trial evaluating the efficacy and safety of LNK01001 in adult patients with moderate to severe Atopic Dermatitis (AD) in China. Led by Professor Jianzhong Zhang and Professor Cheng Zhou from the Department of Dermatology, Peking University People's Hospital, the study is being conducted at multiple clinical research centers nationwide.

The results of the completed Phase II clinical study of LNK01001 for the treatment of Atopic Dermatitis have demonstrated promising efficacy. After 12 weeks of treatment, significant improvements in the condition of patients in both high and low dose groups were observed, meeting the primary endpoints. LNK01001 also demonstrated rapid onset of action, with significant improvement in pruritus indices within 24 hours after dosing in both the high and low dose groups compared to the placebo group. It also exhibited excellent overall safety, with no observations of major cardiovascular adverse events, thrombosis, severe infections, or malignancies that have been associated with other approved JAK inhibitors on the market.

Dr. Henry Wu, Chief Development Officer of Lynk Pharmaceuticals, said, "The dosing of the first patient in the Phase Ⅲ clinical study of LNK01001 for the treatment of Atopic Dermatitis marks an important milestone since the initiation of the Phase Ⅲ clinical trial of this project. We look forward to validating the sustained and reliable therapeutic effects of LNK01001 for patients with Atopic Dermatitis, thereby improving their quality of life."

"LNK01001 has been dosed in over 800 subjects worldwide, including approximately 100 subjects in Phase I clinical trials conducted in Australia and over 700 patients in China, providing preliminary evidence of the drug candidate's efficacy and safety," said Dr. Zhao-Kui (ZK) Wan, Chairman and CEO of Lynk Pharmaceuticals. "We hope that LNK01001 will demonstrate better performance in the Phase III clinical study and have the opportunity to provide a better treatment option for patients."

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