InnoCare Begins Dosing in Phase III Trial of TYK2 Inhibitor for Atopic Dermatitis in China

3 December 2024
InnoCare Pharma has initiated a Phase III registrational trial for its innovative TYK2 inhibitor, ICP-332, aimed at treating atopic dermatitis (AD) in China. As a pioneering biopharmaceutical firm, InnoCare specializes in addressing cancer and autoimmune disorders. The commencement of this trial marks a significant milestone in the company's ongoing efforts to provide effective treatments for various autoimmune conditions.

ICP-332 is a highly potent and selective TYK2 inhibitor developed to manage a range of T-cell related autoimmune diseases, such as atopic dermatitis, vitiligo, and inflammatory bowel disease. This inhibitor targets TYK2, a critical enzyme in the JAK-STAT signaling pathway, which plays a vital role in the development of inflammatory conditions. Despite the extensive research and development in this area, no TYK2 inhibitors have yet been approved globally for the treatment of AD.

The China Phase II study of ICP-332 demonstrated noteworthy results, achieving multiple efficacy endpoints for patients with moderate-to-severe atopic dermatitis. This suggests that ICP-332 has a promising safety and efficacy profile, potentially surpassing other therapies available for AD treatment. However, it is important to note that these findings are not based on direct comparative studies.

The global burden of atopic dermatitis is significant, with the World Health Organization's Global Burden of Disease Study estimating approximately 230 million sufferers worldwide. This makes AD the most burdensome nonfatal skin disease. In China, the incidence of atopic dermatitis is continually rising, highlighting the urgent need for effective treatment options.

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, emphasized the extensive impact of autoimmune diseases, which can affect nearly every organ and occur at any age. She reiterated InnoCare's commitment to advancing autoimmune therapies by focusing on both B-cell and T-cell pathways. Dr. Cui highlighted the company's robust pipeline of therapeutics, including orelabrutinib (a BTK inhibitor), ICP-332 (a TYK2-JH1 inhibitor), ICP-488 (a TYK2-JH2 inhibitor), and a novel small molecule inhibitor of IL-17. These therapeutics have significant market potential globally, and InnoCare is dedicated to expediting their clinical development to benefit patients suffering from autoimmune diseases.

InnoCare is a commercial stage biopharmaceutical company that focuses on the discovery, development, and commercialization of first-in-class and best-in-class drugs for cancer and autoimmune diseases with unmet medical needs. The company has established branches in several major cities, including Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States, which underscores its commitment to addressing global health challenges.

The initiation of the Phase III trial for ICP-332 represents a pivotal advancement in the potential treatment landscape for atopic dermatitis and possibly other autoimmune diseases. With continued research and clinical development, InnoCare aims to bring this innovative therapy to market, providing new hope for millions of patients around the world. The ongoing dedication to discovering and developing novel therapeutics underscores InnoCare's role as a leader in the biopharmaceutical industry, focusing on transformative treatments for chronic and debilitating conditions.

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