Lynk Pharmaceuticals has reported positive data from its Phase Ib clinical trial of LNK01004, a new treatment for atopic dermatitis.
The randomised, double-blind, placebo-controlled, multicentre trial was designed to assess the safety, tolerability, and pharmacokinetic profile of LNK01004 when applied topically to adults with mild to moderate atopic dermatitis.
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The trial demonstrated that the ointment was well-tolerated and safe for up to four weeks of topical application.
No significant skin irritation was reported and no participants withdrew from the study.
The 1% dose group of LNK01004 showed particularly promising efficacy outcomes.
After four weeks of treatment, the group achieved EASI-75, IGA 0/1, and PP-NRS4 response rates of 63%, 50%, and 75%, respectively.
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By GlobalDataLNK01004 is a skin-restricted JAK inhibitor that is applied topically, with extremely low systemic exposure.
In both healthy subjects and atopic dermatitis patients , the maximum detectable drug concentration in the blood was approximately 0.1ng/ml, significantly lower than the JAK human whole blood IC50, indicating a minimal risk of systemic safety concerns, the company noted.
Atopic dermatitis is a chronic skin condition that causes significant discomfort and impact on the quality of life due to its recurrent nature and long-term progression.
Lynk Pharmaceuticals CEO and chairman Dr Zhao-Kui Wan said: “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.”
In December last year, the company dosed the first subject in a Phase III clinical trial of its JAK1 inhibitor, LNK01001, to treat rheumatoid arthritis.
