InnoCare Pharma announced that the FDA has cleared its investigational new drug (IND) application for its novel TYK2 (Tyrosine Kinase 2) inhibitor, ICP-332.

ICP-332 is a potent and selective TYK2 inhibitor. It achieved multiple efficacy endpoints in the China phase 2 study for the treatment of patients with moderate-to-severe atopic dermatitis (AD), demonstrating an outstanding efficacy and safety profile, according to InnoCare. ICP-332 showed better efficacy profile across different classes/MoAs of therapies for the treatment of AD patients (not a head-to-head comparison). The detailed data was presented at the 2024 American Academy of Dermatology (AAD) annual meeting as a late-breaking oral presentation.

Currently, no TYK2 inhibitors have obtained marketing approval for the treatment of AD anywhere in the world. As a non-receptor tyrosine kinase, TYK2 is a member of the JAK kinase family, which is a kinase on the JAK-STAT signaling pathway and plays an important role in the pathogenesis of inflammatory diseases.

"InnoCare is dedicated to targeting the global frontier in autoimmune therapy by focusing on B-cell and T-cell pathways," Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said in a company news release. "We have developed 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 ICP-923 (IL-17 small molecule inhibitor). We are committed to accelerating clinical development and look forward to our innovative drugs benefiting patients with autoimmune diseases as early as possible."