InnoCare Doses First Subject in Phase III Trial of TYK2 Inhibitor ICP-332 for Atopic Dermatitis

Key Insights

• InnoCare initiated a Phase III registrational trial in China for ICP-332, a TYK2 inhibitor, targeting atopic dermatitis (AD).
• ICP-332, a selective TYK2 inhibitor, is under development for T-cell-related autoimmune disorders, showcasing promising efficacy and safety.
• The Phase II study in China demonstrated ICP-332's efficacy in moderate-to-severe AD, outperforming other AD therapies (non-head-to-head).

InnoCare Pharma has announced the dosing of the first subject in its Phase III registrational trial of ICP-332, a novel TYK2 (Tyrosine Kinase 2) inhibitor, for the treatment of atopic dermatitis (AD) in China. This trial marks a significant step in addressing the growing unmet need for effective AD treatments in the region.

ICP-332 is a potent and selective TYK2 inhibitor designed to treat various T-cell-related autoimmune disorders, including atopic dermatitis, vitiligo, and inflammatory bowel disease. TYK2, a member of the JAK kinase family, plays a crucial role in the JAK-STAT signaling pathway, which is central to the pathogenesis of inflammatory diseases.

Clinical Efficacy and Safety Profile

Currently, there are no approved TYK2 inhibitors for atopic dermatitis globally. In a Phase II study conducted in China, ICP-332 demonstrated promising efficacy and safety results in patients with moderate-to-severe atopic dermatitis. The study indicated that ICP-332 had a better efficacy profile compared to other therapies for AD, although the comparison was not conducted head-to-head.

Addressing the Global Burden of Atopic Dermatitis

According to the World Health Organization's Global Burden of Disease Study, atopic dermatitis affects approximately 230 million people worldwide, making it the skin disease with the highest disease burden among nonfatal diseases. The prevalence of atopic dermatitis is increasing in China, highlighting the urgent need for new and effective treatment options.

InnoCare's Commitment to Autoimmune Disease Therapy

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, stated, "InnoCare is dedicated to advancing the global frontier in autoimmune therapy by focusing on B-cell and T-cell pathways. We have developed a robust pipeline of differentiated therapeutics for autoimmune disease with significant market potential worldwide, including orelabrutinib (BTK inhibitor), ICP-332 (TYK2-JH1 inhibitor), ICP-488 (TYK2-JH2 inhibitor) and the novel small molecule inhibitor of IL-17. We are committed to accelerating clinical development and look forward to our innovative drugs benefiting patients with autoimmune diseases."