Lynk Pharmaceuticals, a clinical-stage company, has reported positive results from its Phase 1b clinical trial of LNK01004 for the treatment of atopic dermatitis.
LNK01004 ointment is a skin-restricted, soft-pan Janus kinase (JAK) inhibitor.
The study was a randomised, double-blind, placebo-controlled, multicentre clinical trial designed to assess the safety, tolerability, and pharmacokinetics of LNK01004.
In the trial, the ointment was applied topically to adult patients with mild to moderate atopic dermatitis over four weeks.
According to the results, LNK01004 was well-tolerated and safe for up to four weeks of use, with no significant skin irritation reported and no patient dropped out of the study.
The 1% dose group of LNK01004 showed the most promising efficacy. The group achieved EASI-75, IGA 0/1, and PP-NRS4 response rates of 63%, 50%, and 75%, respectively, compared to 17%, 17%, and 33% in the placebo group.
Based on the recent data, China-based Lynk Pharmaceuticals plans to assess the asset in further clinical trials.
Lynk Pharmaceuticals chairman and CEO 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 the 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.
“LNK01004 can effectively inhibit multiple inflammatory cytokines, it has the potential to treat various immune diseases including atopic dermatitis, psoriasis, alopecia areata, etc.”
In December last year, Lynk Pharmaceuticals dosed the first patient in the Phase 3 clinical trial of its LNK01001 for rheumatoid arthritis (RA) treatment.
The clinical-stage firm completed a CNY200m Series C1 financing round in May 2023.
Recently, US-based Arcutis Biotherapeutics received the US Food and Drug Administration (FDA) approval for Zoryve (roflumilast) cream to treat atopic dermatitis.