Jiangsu Vcare's VC005 Demonstrated Positive Results in the Phase II Clinical Trial for the Oral Treatment of Ankylosing Spondylitis

　　Recently, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) reported positive results from its Phase II clinical trial of VC005 tablets, a second-generation selective JAK1 inhibitor, for the treatment of ankylosing spondylitis (AS).

　　Efficacy: Low-dose group demonstrated significant improvements in the primary efficacy endpoint compared to placebo, with efficacy comparable to the active comparator tofacitinib. High-dose group showed no worsening of efficacy metrics relative to tofacitinib.

　　Safety: Overall safety and tolerability were favorable, with no dose-related adverse reactions observed. Combined incidence of Grade 3 or higher TEAEs, TEAEs leading to discontinuation, and SAEs across all dose groups were low, comparable to placebo and significantly lower than tofacitinib.

　　VC005 tablets are nearing completion of Phase II development in AS, with Phase III trials scheduled to commence in the second half of this year.

　　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 JAK1

　　The JAK/STAT signaling pathway, mediated by JAK family kinases and downstream STAT transcription factors, plays a critical role in regulating inflammatory and autoimmune diseases such as AS and AD. Current first-generation pan-JAK inhibitors(e.g., Tofacitinib) broadly suppress multiple JAK subtypes, particularly JAK2, leading to significant safety concerns. This has prompted the U.S. FDA to issue black box warnings for such drugs. Second-generation selective JAK1 inhibitors, like VC005, aim to deliver enhanced safety and efficacy, positioning them as superior therapeutic options.

　　About Ankylosing Spondylitis (AS)

　　AS is a chronic inflammatory disease primarily affecting the sacroiliac joints, spine, paravertebral soft tissues, and peripheral joints, potentially causing structural damage, spinal deformity, and disability.

　　Prevalence: The Prevalence of AS in China is approximately 0.36%, affecting over 5 million individuals. Demographics: AS predominantly affects males aged between 15–40, with onset typically occur before the age of 35. Pathogenesis: The pathogenesis of AS is linked to genetic, infectious, environmental, and immunological factors. The disease progresses over time, often resulting in irreversible damage. Treatment: JAK inhibitors, as non-immunogenic small-molecule drugs, avoid secondary failure caused by neutralizing antibodies (common with biologics), offering a promising therapeutic approach.