Jiangsu Vcare’s Second-Generation Selective JAK1 Inhibitor VC005 Completes Phase II Enrollment for Moderate-to-Severe Atopic Dermatitis

　　Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced the completion of Phase II clinical enrollment for its self-developed second-generation selective JAK1 inhibitor VC005 tablets in the treatment of moderate-to-severe atopic dermatitis (AD). Preliminary blinded analysis from the clinical trial demonstrated promising efficacy and safety profiles for VC005.

　　About VC005

　　VC005 is a novel, highly potent, and selective JAK1 inhibitor independently developed by Jiangsu Vcare. By selectively inhibiting JAK1, the drug suppresses immune cell-mediated cytotoxicity and immune responses, while exhibiting minimal inhibitory activity against JAK2, JAK3, and TYK2 (based on preclinical data). This selectivity is expected to mitigate safety concerns associated with excessive inhibition of non-target JAK isoforms, such as JAK2.

　　The drug is under development in two formulations: ① Oral tablets: Phase II trials for ankylosing spondylitis (AS)and moderate-to-severe AD are ongoing. Enrollment for the AS trial was completed by the end of 2023. Additional clinical indications, including IBD and RA, have been approved. Early Phase I studies demonstrated favorable pharmacokinetics, safety, and tolerability. ② Topical gel: Phase I trials for mild-to-moderate AD are nearing completion.

　　About JAK1

　　The JAK/STAT signaling pathway plays a critical role in the pathogenesis of inflammatory diseases such as AD. Current oral JAK inhibitors lack sufficient selectivity, simultaneously inhibiting JAK1, JAK2, and JAK3, which has been linked to severe adverse events (e.g., anemia, infections, dyslipidemia, malignancies) and prompted the U.S. FDA to issue black box warnings. Since the first half of 2021, the FDA has repeatedly delayed reviews of pan-JAK inhibitors, raising concerns in the biopharmaceutical industry. Consequently, the development of highly selective JAK1 inhibitors has become imperative. To date, no selective JAK1 inhibitors for AD have been approved in China, underscoring the urgent unmet clinical need.

　　VC005 was designed with a differentiated approach, addressing these challenges during its discovery and development phases. Preclinical studies showed that VC005 achieves lower effective doses, higher tolerated doses, and reduced side effects compared to other JAK1-targeted drugs. Early human trials further confirmed its favorable metabolic profile and safety, positioning VC005 as a potential global leader in the treatment of autoimmune and inflammatory diseases.

　　About AD

　　AD is a chronic, recurrent, inflammatory skin disorder characterized by dry skin, intense pruritus, and eczematous lesions. The disease severely impairs patients’ quality of life. Globally, AD affects approximately 230 million individuals, with over 70 million cases in China (adult prevalence: 2%-8%). Among these, 33% are moderate-to-severe cases, and prevalence continues to rise.

　　Current treatments rely on topical and systemic therapies, but traditional options (e.g., glucocorticoids) are limited by adverse effects and suboptimal efficacy, leaving many patients without stable disease control. In contrast, oral JAK1 inhibitors, as non-glucocorticoid immunosuppressants, offer a targeted approach with improved safety and prolonged therapeutic responses, providing a superior alternative for moderate-to-severe AD patients.