InnoCare Pharma has announced the dosing of the first subject in its Phase III registrational trial of ICP-332, a novel Tyrosine Kinase 2 (TYK2) inhibitor, for the treatment of atopic dermatitis (AD) in China. This Phase III trial marks a significant step forward in addressing the high unmet medical need for AD patients in China and worldwide.
ICP-332: A Novel TYK2 Inhibitor
ICP-332 is a potent and selective TYK2 inhibitor developed by InnoCare for various T-cell related autoimmune disorders, including atopic dermatitis, vitiligo, and inflammatory bowel disease. TYK2, a non-receptor tyrosine kinase and a member of the JAK kinase family, plays a crucial role in the JAK-STAT signaling pathway, which is implicated in the pathogenesis of inflammatory diseases. Currently, there are no approved TYK2 inhibitors for AD treatment globally.
Promising Phase II Results
InnoCare's ICP-332 has demonstrated encouraging results in a Phase II study conducted in China for patients with moderate-to-severe atopic dermatitis. The study met multiple efficacy endpoints and exhibited an outstanding efficacy and safety profile. According to the company, ICP-332 also showed a better efficacy profile across different classes/MoAs of therapies for the treatment of AD patients (not a head-to-head comparison).
Addressing a Significant Unmet Need
The global burden of atopic dermatitis is substantial, with approximately 230 million patients worldwide, according to the World Health Organization's Global Burden of Disease Study. This makes AD the skin disease with the highest disease burden among nonfatal diseases. In China, the prevalence of atopic dermatitis continues to rise, highlighting the urgent need for effective treatments.
InnoCare's Broader Autoimmune Portfolio
Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, emphasized the company's commitment to advancing autoimmune therapy by targeting B-cell and T-cell pathways. InnoCare has developed a robust pipeline of differentiated therapeutics for autoimmune diseases with significant market potential worldwide, including orelabrutinib (BTK inhibitor), ICP-332 (TYK2-JH1 inhibitor), ICP-488 (TYK2-JH2 inhibitor), and a novel small molecule inhibitor of IL-17. The company aims to accelerate clinical development to benefit patients with autoimmune diseases.
