Jiangsu Vcare's Oral Treatment VC005 for Atopic Dermatitis enters Phase III Clinical Study
Published Time:
2024-10-22 17:33
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VC005 tablets, developed by Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare), is a new-generation highly selective JAK1 inhibitor. The oral treatment of moderate-to-severe atopic dermatitis has initiated a Phase III clinical trial. It is a multicenter, randomized, double-blind, placebo parallel-controlled Phase III clinical study, aiming to evaluate the efficacy and safety of VC005 tablets for adult patients with moderate-to-severe atopic dermatitis. The trial is led by the Institute of Dermatology, Chinese Academy of Medical Sciences.
Positive top-line data has been obtained from the unblinded Phase II clinical study, showing key indicators, that are superior to the best drugs of the same class. Meanwhile, the overall safety and tolerability of the drug are good. In particular, adverse reactions related to the blood system in the high-dose group are milder than those of other drugs the same class, and no bone marrow suppression effect is observed.
In addition, VC005 is also being developed as a topical gel for patients with mild-to-moderate atopic dermatitis. The Phase II clinical trial is about to be initiated, and the project plans to expand its indications for atopic dermatitis in the future.
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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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