The board of directors of InnoCare Pharma Limited announced the positive top-line results from the phase II randomized, double-blind, placebo-controlled study of ICP-332, an once-daily oral inhibitor of TYK-2, in adult patients with moderate-to-severe atopic dermatitis (AD). As a non-receptor tyrosine kinase, TYK2 is a member of the JAK kinase family, which is an important kinase on the JAK-STAT signaling pathway in T cells, playing an important role in the pathogenesis of inflammatory diseases. ICP-332 is a potent and selective TYK-2 inhibitor with about 400 folds of selectivity against JAK2 to avoid the adverse events associated with non-selective JAK inhibitors.

The phase II study is a randomized, double-blind, placebo-controlled trial evaluating the safety, efficacy, pharmacokinetics, and pharmacodynamics of ICP-332 in moderate-to-severe atopic dermatitis. Patients with AD treated with ICP-332 for 4 weeks showed excellent efficacy and safety profile. ICP-332 achieved multiple efficacy endpoints including Eczema Area and Severity Index ("EASI") 50, EASI 75, EASI 90 (improvement of at least 50%, 75%, and 90% in EASI score from baseline) and Investigator's Global Assessment (IGA) 0/1 (score of 0 (clear) or 1 (almost clear)) in ICP-332 80mg and/or 120mg group respectively.

The mean percentage change from baseline in the EASI score, a measure of the eczema area and severity of atopic dermatitis, reached to 78.2% at 80mg once-daily dosing with a highly significant P value (p<0.0001) and 72.5% at 120mg once-daily dosing with a highly significant P value (p<0.0001) compared to 16.7% for patients receiving placebo. EASI 75 reached to 64%/64% at 80mg and 120mg dosing respectively, compared to 8% percent for patients receiving placebo (p<0.0001). In this study, all treatment-related adverse events (TRAEs) were mild or moderate, which is comparable to those from receiving placebo.

The Company will continue to evaluate the potential of ICP-332 in phase III of atopic dermatitis and across multiple immune-mediated diseases. ICP-332 is an investigational oral agent and is not approved by regulatory authorities.