Study Results of Novel TYK2 Inhibitor Soficitinib in Patients with AD Published by JAMA Dermatology

Core Insights - The Phase II study of soficitinib, a novel TYK2 inhibitor, shows promising safety and efficacy for treating moderate-to-severe atopic dermatitis (AD) [1][6] Study Design and Results - The study was a double-blind, placebo-controlled trial with 75 participants randomized to receive either soficitinib at 80 mg, 120 mg, or a placebo [2] - The primary endpoint focused on safety and efficacy, with key efficacy measured by the percentage change in Eczema Area and Severity Index (EASI) at week 4 [2] - Soficitinib demonstrated significant efficacy, with percentage improvements in EASI at week 4 being 78.2% for the 80 mg group, 72.5% for the 120 mg group, and 16.7% for the placebo group [3] Efficacy Endpoints - Both soficitinib doses achieved a statistically significant higher EASI-75 response rate of 64.0% compared to a 56.0% difference from placebo [3] - The 80 mg soficitinib group had a greater percentage of patients achieving a Validated Investigator Global Assessment score of 0 or 1, with a 36.0% response rate compared to 4.0% in the placebo group [3] Quality of Life and Pruritus Relief - Soficitinib provided rapid relief from pruritus, with significant improvements observed as early as day 2, peaking at week 4 [4] - In the soficitinib groups, 72.0% of patients achieved an improvement of 4 points or more at week 4, compared to 16.0% in the placebo group [4] Safety Profile - Soficitinib exhibited a favorable safety profile, with treatment-related adverse events being mild or moderate, comparable to placebo [5] - All treatment-emergent adverse events in the 80 mg group were mild [5] Future Development - Patient enrollment for the Phase III clinical trial of soficitinib in AD has been completed, with 579 patients enrolled [8] - Soficitinib is also being developed for other T-cell related autoimmune disorders, including vitiligo, with a Phase II trial completed for 162 patients [8] Company Overview - InnoCare is a biopharmaceutical company focused on developing first-in-class and best-in-class drugs for cancers and autoimmune diseases, with operations in China and the United States [9]