Jiangsu Vcare's VC005 has Achieved Positive Topline Data in the Phase II Clinical Trial for the Oral Treatment of Atopic Dermatitis

　　Recently, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) announced positive topline data from its Phase II clinical trial of VC005 tablets, a second-generation selective JAK1 inhibitor, for the oral treatment of moderate-to-severe atopic dermatitis (AD).

　　Study Design: The trial was a randomized, double-blind, placebo-controlled, multicenter Phase II study evaluating the efficacy and safety of VC005 tablets in adults with moderate-to-severe AD. The primary endpoint was the percentage change from baseline in EASI score at Week 12.

　　Key Results:

　　Primary Endpoint Achieved: All three dose groups (high, medium, low) met the primary endpoint, demonstrating significant improvements in EASI scores compared to placebo, with a clear dose-dependent efficacy trend.

　　Secondary Endpoints: EASI-75(≥75% reduction in EASI score from baseline) and EASI-90(≥90% reduction) response rates in all VC005 dose groups were significantly higher than placebo. Investigator’s Global Assessment (IGA) response rates also showed superiority over placebo.

　　Efficacy outcomes were comparable to or surpassed those of leading same-class therapies.

　　Rapid Pruritus Relief: VC005 tablets reduced itching severity (measured by NRS) within 1 week, with complete itch resolution (NRS=0) observed as early as the first dosing day.

　　Subgroup Analysis: In patients previously treated with JAK inhibitors, medium- and high-dose VC005 groups still exhibited robust efficacy, unlike similar drugs that often exclude such populations.

　　Safety: VC005 was well-tolerated, with TRAEs comparable to placebo across all dose groups.

　　Following the unblinding of Phase II data for both moderate-to-severe AD and ankylosing spondylitis (AS), Jiangsu Vcare plans to initiate Phase III clinical trials within this year.

　　About VC005

　　VC005 is a novel, potent, and highly selective second-generation JAK1 inhibitor independently developed by Jiangsu Vcare. By selectively inhibiting JAK1, it reduces inflammatory responses and immune cell activation, positioning it as a promising therapy for inflammatory and autoimmune diseases.

　　Compared to Upadacitinib (a marketed JAK inhibitor), VC005 exhibits lower JAK2 inhibitory activity (based on in vitro kinase assays), potentially mitigating safety concerns associated with excessive JAK2 inhibition. Oral Tablet formulation of VC005 is currently in Phase II trials for AS and moderate-to-severe AD, both studies demonstrated positive interim results. The topical Gel formulation is now in Phase I for mild-to-moderate AD, with data aligning with project expectations.

　　About Atopic Dermatitis (AD)

　　AD is a chronic, relapsing, inflammatory skin disease characterized by dry skin, intense itching, and eczematous lesions, severely impacting patients’ quality of life. Epidemiologically: The global number of patients is approximately 230 million cases. Adult AD prevalence in China: 2%–8%, affecting over 70 million individuals (67% mild, 33% moderate-to-severe). Projected growth: F&S forecasts a 1.7% compound annual growth rate (CAGR) in disease burden from 2025 to 2030. Oral JAK1 inhibitors, such as VC005, offer effective disease control, prolonged therapeutic response, and enhanced safety, providing superior treatment options for moderate-to-severe AD patients.