Jiangsu Vcare Announces Successfully Unblinding of VC005 Topical Gel Clinical Phase I Data
Published Time:
2024-08-16 17:23
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Recently, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) announced the successful unblinding of Phase I clinical data for its self-developed VC005 gel, a second-generation selective JAK1 inhibitor, in the topical treatment of mild-to-moderate atopic dermatitis (AD). The results demonstrated exceptional safety and significant efficacy.
The trial primarily evaluated the "safety, tolerability, PK profile", and preliminary efficacy of VC005 Gel in healthy adult subjects and patients with mild-to-moderate AD.
Safety & Tolerability: VC005 gel exhibited a favorable safety profile, with no significant dose-related increase in adverse events (AEs). The incidence of AEs in dose groups was comparable to that in the vehicle control group.
Low Systemic Exposure: Minimal plasma exposure following topical application indicated a very low risk of systemic adverse reactions.
Rapid Anti-Pruritic Effect: VC005 Gel demonstrated excellent efficacy against pruritus, with symptom improvement observed within 1 hour post-application.
Clinical Improvements: at Week 4, all dose groups exhibited significant improvements in EASI, DLQI, NRS, and BSA affected by lesions compared to baseline.
Dose-Dependent Efficacy: All tested doses demonstrated a dose-dependent reduction in skin lesions and other clinical symptoms, significantly enhancing patients’ quality of life.
The VC005 program is currently in development for multiple indications, including AD and ankylosing spondylitis (AS), with both oral and topical formulations. It is expected to provide safer and more effective therapeutic options for patients.
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.
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