Jiangsu Vcare Completes Participants Enrollment in Phase I Clinical Trial of Topical VC005 for Atopic Dermatitis

　　Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced the completion of participants enrollment in its Phase I clinical trial for VC005, a second-generation selective JAK1 inhibitor developed as a topical gel formulation for the treatment of mild-to-moderate atopic dermatitis (AD). The trial included four cohorts of healthy volunteers and three cohorts of patients. The blinded analysis demonstrated promising efficacy and safety profiles for the drug.

　　This milestone follows the earlier completion of patient enrollment in the Phase II clinical trial of oral VC005 tablets for moderate-to-severe AD, marking another critical advancement in the drug’s development for the same indication via a topical route. Topical efficacy and safety data are expected to undergo statistical analysis by mid-2024. Currently, no topical JAK inhibitors have been approved by the NMPA in China. VC005’s development aims to address this unmet medical need and provide patients with a superior therapeutic option.

　　About VC005

　　VC005 is a novel, highly potent, and selective second-generation JAK1 inhibitor independently developed by Jiangsu Vcare. By selectively inhibiting JAK1, the drug reduces inflammatory responses and immune cell activation, thereby achieving therapeutic effects in inflammatory and autoimmune diseases. Compared to Upadacitinib(a currently marketed JAK inhibitor), VC005 exhibits lower JAK2 inhibitory activity(based on in vitro kinase assays), which may mitigate safety concerns associated with excessive JAK2 inhibition.

　　The drug is currently being developed in two formulations:

　　Oral tablets: Phase II trials for ankylosing spondylitis (AS)and moderate-to-severe AD have completed patient enrollment, with data unblinding anticipated by mid-2024.

　　Topical gel: Targeting mild-to-moderate AD, Phase I development is progressing intensively.

　　About JAK1

　　The JAK/STAT signaling pathway, mediated by JAK family kinases and downstream STAT transcription factors, plays a critical regulatory role in inflammatory and autoimmune diseases such as AS and AD. Current first-generation pan-JAK inhibitors non-selectively inhibit multiple JAK subtypes (e.g., JAK1, JAK2, JAK3, TYK2) at similar potency levels. Excessive JAK2 inhibition is associated with severe adverse events, prompting the U.S. FDA to issue black box warnings for these agents. Consequently, second-generation selective JAK1 inhibitors like VC005, designed for enhanced safety and efficacy, represent a necessary evolution in therapy.

　　About AD

　　AD is a chronic, recurrent, inflammatory skin disease characterized by dry skin, intense pruritus, and eczematous lesions, significantly impairing patients’ quality of life. Epidemiological data indicate that AD affects up to 230 million individuals globally, including 70 million in China, with two-thirds classified as mild and one-third as moderate-to-severe. Prevalence continues to rise.

　　Traditional therapies such as glucocorticoids are limited by adverse effects and poor long-term outcomes, while treatment options for moderate-to-severe patients remain scarce, leaving many without stable disease control. VC005’s development holds promise for bridging this gap.