By Fineline Cube 
China-based InnoCare Pharma (HKG: 9969, SHA: 688428) announced the oral presentation of results from the Phase II study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor ICP-488 in psoriasis vulgaris at the American Academy of Dermatology Annual Meeting (AAD). The results demonstrate significant improvements in patients treated with ICP-488 compared to the placebo group.
Study Design and Patient Population
The Phase II study randomized 129 psoriasis patients into three groups in a 1:1:1 ratio. Patients received 12 weeks of treatment in either the 6mg QD group, 9mg QD group, or placebo group. The primary endpoint was the proportion of patients achieving a 75% improvement in the Psoriasis Lesion Area and Severity Index (PASI75) at week 12.
Efficacy Results
At week 12, the PASI75 response rates in the 6mg QD and 9mg QD groups were 77.3% and 78.6%, respectively, significantly higher than the placebo group’s 11.6% (P<0.0001). Additionally, the PASI90 response rates in these two dose groups reached 36.4% and 50.0%, respectively, compared to 0% in the placebo group (P<0.0001). The static Psoriasis Global Assessment (sPGA) 0/1 response rates were 70.5% and 71.4% in the treatment groups, versus 9.3% in the placebo group (P<0.0001).
Mechanism of Action
ICP-488 is a potent and selective TYK2 allosteric inhibitor being developed for the treatment of psoriasis and other autoimmune diseases. By binding to the JH2 domain, ICP-488 blocks the signal transduction of inflammatory cytokines such as IL-23, IL-12, and type 1 IFN, thereby inhibiting the pathological process of autoimmune and inflammatory diseases.
Implications and Future Development
These positive Phase II results position ICP-488 as a promising therapeutic option for psoriasis vulgaris. InnoCare Pharma plans to continue advancing the development of ICP-488, with further clinical trials expected to explore its efficacy and safety in larger patient populations.-Fineline Info & Tech