Jiangsu Vcare Announces Positive Phase II Results for VC005 Topical Gel, a Second-Generation Highly Selective JAK1 Inhibitor, in the Treatment of Mild-to-Moderate Atopic Dermatitis (AD)

　　Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced that the Phase II clinical study of VC005 topical gel, a self-developed second-generation highly selective JAK1 inhibitor, for the treatment of mild-to-moderate atopic dermatitis (AD) in adults in China has successfully completed unblinding and preliminary analysis, yielding positive results.

　　This trial is a multicenter, randomized, double-blind, vehicle-controlled Phase II clinical study evaluating the efficacy and safety of VC005 gel in adult subjects with mild-to-moderate AD. The results showed that both dose groups met the primary endpoint, with significant improvements in various scores compared to the placebo group (P<0.05). For patients with moderate AD, the IGA response rate after 8 weeks of treatment with 3% VC005 gel was approximately 45%, which was significantly higher than that of the placebo group (Δ32%).

　　VC005 gel demonstrated significant antipruritic effects and skin lesion recovery in the early stage of treatment. Pruritus symptoms began to relieve on the first day of treatment: the average Numerical Rating Scale (NRS) score for pruritus decreased by approximately 14% within 12 hours after application of 1% VC005 gel. Additionally, about 30% of patients achieved ≥50% improvement in skin lesions (EASI-50 response) after 1 week of administration, significantly enhancing patients' quality of life.

　　In terms of safety, the incidence of adverse events was low across all dose groups of VC005 gel, showing good safety and tolerability. No new safety signals were identified compared to similar drugs.

　　The Phase II clinical study of VC005 gel in adolescents aged 12 years and above with mild-to-moderate AD is currently underway. Meanwhile, the enrollment of all subjects in the Phase III clinical trial of oral VC005 tablets for the treatment of moderate-to-severe AD has been completed. Jiangsu Vcare will continue to advance the subsequent clinical development of VC005 for AD and other additional indications, providing more innovative treatment options for patients with inflammatory and autoimmune diseases worldwide.

　　About VC005

　　VC005 is a novel, potent, and highly selective second-generation JAK1 inhibitor, currently developed in two formulations: oral tablets and topical gel. The topical gel formulation of VC005 adopts a unique pharmaceutical matrix, which not only achieves high drug loading but also possesses excellent stability, safety without irritation, and a refreshing gel texture, thereby improving patient medication adherence. In completed clinical trials, VC005 gel has demonstrated good safety and tolerability, with low plasma exposure indicating a very low risk of systemic adverse reactions from cutaneous administration. It exhibits excellent efficacy in relieving pruritus, taking effect immediately after application to rapidly eliminate AD-related pruritic symptoms. As a novel topical gel with targeted JAK1 action and local skin exposure, VC005 gel features low systemic exposure and local efficacy, holding the potential to address the black box warning issue associated with Ruxolitinib cream due to its high systemic exposure.

　　About Atopic Dermatitis

　　Atopic dermatitis (AD) is a chronic, recurrent, inflammatory skin disease characterized by dry skin, intense pruritus, and eczematous rashes, which severely impacts patients' quality of life. Epidemiologically, the global prevalence of AD is approximately 230 million people. In China, the prevalence of AD among adults ranges from 2% to 8%, with over 70 million patients, including 67% with mild cases and 33% with moderate-to-severe cases. According to F&S forecasts, the number of patients will continue to grow at a compound annual growth rate (CAGR) of 1.7% from 2025 to 2030. Traditional therapeutic drugs, such as glucocorticoids, are associated with numerous adverse reactions and fail to provide long-term benefits, making it difficult to achieve effective and stable disease control. In contrast, topical small-molecule JAK1-targeted inhibitors are non-glucocorticoid immunosuppressants, which are expected to retain therapeutic efficacy while further improving the medication safety for patients with mild-to-moderate atopic dermatitis.