The U.S. Food and Drug Administration (FDA) has cleared InnoCare Pharma’s investigational new drug application (IND) for ICP-332, a tyrosine kinase 2 (TYK2) inhibitor that’s being studied in moderate to severe atopic dermatitis (AD).
Currently, no TYK2 inhibitors have obtained marketing approval for the treatment of AD.
ICP-332 achieved multiple efficacy endpoints in the China Phase II study of patients with moderate-to-severe AD and demonstrated an “outstanding” and safety profile. ICP-332 showed better efficacy profile across different classes and mechanisms of action of therapies for the treatment of AD patients although this was not a head-to-head study. The data was presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting.
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, says, “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.”
