LNK01001 Achieves Primary Endpoint in Phase II Trial for Atopic Dermatitis

Lynk Pharmaceuticals Co., Ltd. announced positive topline data from its phase II clinical trial of LNK01001 for adults with atopic dermatitis (AD) today.¹ After 12 weeks of treatment preliminary data showed that patients in the low-dose and the high-dose groups experienced significant improvement from baseline in the Eczema Area and Severity Index (EASI) scores compared to the placebo group.

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The randomized, double-blind, placebo-controlled, multicenter trial evaluated the efficacy of LNK01001 in 150 adults with moderate to severe AD. Study participants had not responded adequately to topical treatment or had previously received other systemic treatment for AD.

Participants were randomly assigned to either the LNK01001 high-dose group, the LNK01001 low-dose group, or a placebo. Patients in both the high- and low-dose groups achieved the primary endpoint at 12 weeks of a statistically significant change from the baseline EASI score.

In addition, the number of patients achieving EASI75 and Investigator’s Global Assessment (IGA) response were significantly higher in the LNK01001 groups than in the placebo group. Participants in the high- and low-dose groups also experienced a rapid onset of improvement in pruritis 24 hours after dosing.

“Controlling itch and clearing skin lesions are the most urgent treatment needs for AD patients,” Professor Jianzhong Zhang, the principal investigator of the study, the 13th director in the Dermatology Division of the Chinese Medical Association and director of the Dermatology Department at Peking University People's Hospital, said in a news release. "The results of this study suggest that LNK01001 has the potential to provide clinical benefits to adult patients with moderate to severe AD. 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."

Both groups receiving LNK01001 treatment exhibited good tolerability with comparable rates of Common Terminology Criteria grade 2+ treatment-emergent adverse events. Serious adverse events were comparable to the placebo group. There were no reports of adverse cardiovascular events, venous thromboembolism, malignancies, or severe infections.

Reference

1. Lynk Pharmaceuticals announced positive topline data from phase II clinical trial of LNK01001 in the treatment of atopic dermatitis. News release. August 9, 2023. Accessed August 9, 2023. https://prnmedia.prnewswire.com/news-releases/lynk-pharmaceuticals-announced-positive-topline-data-from-phase-ii-clinical-trial-of-lnk01001-in-the-treatment-of-atopic-dermatitis-301895890.html