Pharma Focus America

InnoCare Receives FDA Clearance for Clinical Trial of TYK2 Inhibitor ICP-332

Wednesday, June 12, 2024

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focused on treatments for cancer and autoimmune disorders, has received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for its new TYK2 (Tyrosine Kinase 2) inhibitor, ICP-332.

ICP-332 is a potent and selective inhibitor of TYK2, showing significant efficacy in meeting multiple targets in a Phase II study conducted in China for treating moderate-to-severe atopic dermatitis (AD). This drug has demonstrated a favorable safety and effectiveness profile, as highlighted in a late-breaking oral presentation at the 2024 American Academy of Dermatology (AAD) Annual Meeting. While ICP-332 showed superior efficacy compared to other treatments in various classes and mechanisms, it has not been directly compared in a head-to-head study.

TYK2, a member of the JAK kinase family and a non-receptor tyrosine kinase, is critical in the JAK-STAT signaling pathway and plays an important role in inflammatory disease processes. No TYK2 inhibitors have yet been approved for AD treatment globally.

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, remarked, "InnoCare is focused on pushing the boundaries of autoimmune therapy, particularly through our work with B-cell and T-cell pathways. Our pipeline of innovative treatments for autoimmune diseases holds significant global market potential. Alongside ICP-332, our portfolio includes orelabrutinib (BTK inhibitor), ICP-488 (TYK2-JH2 inhibitor), and ICP-923 (IL-17 small molecule inhibitor). We are committed to accelerating the clinical development of our drugs and are excited to bring these innovative therapies to patients with autoimmune diseases at the earliest opportunity."



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