Jiangsu Vcare Launches Phase II Trial for VC005 Topical Gel in Mild-to-Moderate Atopic Dermatitis
Published Time:
2025-03-26 18:05
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On March 26, 2025, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) officially launched the Phase II clinical trial for its self-developed, highly selective JAK1 inhibitor VC005 gel for the topical treatment of mild-to-moderate atopic dermatitis (AD). The completed Phase I clinical study of VC005 gel demonstrated excellent safety and significant efficacy.
Currently, the oral tablet formulation of VC005 for moderate-to-severe AD has completed the first dosing of patients in Phase III clinical trials, with favorable safety results.
About VC005
VC005 is a novel, potent, and highly selective second-generation JAK1 inhibitor independently developed by Jiangsu Vcare. By selectively inhibiting JAK1, the drug reduces inflammatory responses and immune cell activation, making it clinically applicable for treating inflammatory and autoimmune diseases. Compared to the marketed leading drug Upadacitinib, VC005 exhibits lower JAK2 inhibitory activity (based on in vitro kinase assay results), potentially mitigating safety concerns associated with excessive JAK2 inhibition. The oral tablet formulation of VC005 is actively undergoing a Phase II clinical trial for ankylosing spondylitis and a Phase III trial for moderate-to-severe AD, which have yielded positive results. The topical gel formulation for mild-to-moderate AD has completed Phase I studies, demonstrating outstanding safety and efficacy.
About Atopic Dermatitis (AD)
Atopic dermatitis is a chronic, recurrent, inflammatory skin disease characterized by dry skin, intense itching, and eczematous rashes. The disease significantly impairs patients' quality of life. Epidemiologically, the global AD patient population is approximately 230 million, with an adult prevalence rate of 2%–8% in China, affecting over 70 million individuals. Among these, 67% are mild cases and 33% are moderate-to-severe. Frost & Sullivan predicts that the number of cases will grow at a compound annual growth rate (CAGR) of 1.7% from 2025 to 2030. Traditional treatments, such as glucocorticoids, are associated with numerous adverse reactions and limited long-term benefits, making disease control challenging. Meanwhile, topical JAK1 small-molecule targeted inhibitors, as non-glucocorticoid immunosuppressants, offer promising efficacy and safer choices for mild-to-moderate AD patients.
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I. Important Progress in Innovative Drug R&D ① Submitted NDA to US FDA for anti-platelet drug Vicagrel: If approved, it may benefit ~27.6M US patients with coronary heart disease/stroke. ② Completed 1st patient enrollment in China’s Phase II trial for anti-resistant TRK inhibitor VC004: Phase I data showed ORR of 80%-90% in NTRK fusion+ solid tumors and DOR up to 24 months. ③ Completed Phase II enrollment for 2nd-gen selective JAK1 inhibitor VC005 in ankylosing spondylitis: Preliminary blinded analysis showed favorable efficacy/safety. Additionally: VC004 gel approved for clinical trials; VC005 gel initiated China Phase I for atopic dermatitis; Multiple preclinical projects advanced in cardio-cerebrovascular, oncology, and autoimmune fields.
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