First dosing of patient in Phase III Clinical trial of Jiangsu Vcare's VC005 Tablets for Moderate-to-Severe Atopic Dermatitis
Published Time:
2024-12-30 17:36
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On December 30, 2024, the first administration of VC005 tablets was completed in the Phase III clinical trial of oral treatment of moderate-to-severe atopic dermatitis (AD). VC005 is a new-generation highly selective JAK1 inhibitor independently developed by Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare). Positive top-line data were obtained from the unblinded Phase II clinical study of VC005 for AD, with primary endpoints showing superiority over the best drugs in the same class. Meanwhile, the overall safety and tolerability of the drug are good. In particular, the decreases in neutrophil and platelet counts caused by high dosage VC005 were smaller, compared with the positive control group of tofacitinib, and no significant reduction in lymphocyte count was observed.
About VC005
VC005 is a novel, potent, and highly selective new-generation JAK1 inhibitor independently developed by Jiangsu Vcare. By selectively inhibiting JAK1, the drug reduces the inflammatory response and the activation of immune cells, making it clinically applicable for treating inflammatory and autoimmune diseases. Compared to Upadacitinib, a leading marketed drug in the same class, VC005 more selectively reduces JAK2 inhibitory activity (based on in vitro kinase assay results), potentially alleviating safety concerns associated with excessive JAK2 inhibition in clinical settings.
About Atopic Dermatitis
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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