Nuochengjianhua (09969) orally reported the latest clinical data on TYK2 inhibitors.
The Zhitong Finance App learned that on March 11, Nuochengjianhua (09969) announced that the latest phase 2 clinical data on the treatment of moderate to severe atopic dermatitis (AD) with the novel TYK2 inhibitor ICP-332 will be released in the form of a major oral presentation (late-breaking oral presentation) at the 2024 American Academy of Dermatology annual meeting. ICP-332 is a highly selective oral TYK2 inhibitor. Previously, its phase 2 clinical study for the treatment of severe atopic dermatitis had reached a major end.
ICP-332 is an efficient and highly selective novel oral TYK2 inhibitor independently developed by Nuochengjianhua. It has strong inhibitory activity against TYK2. TYK2 is a non-receptor tyrosine kinase. It belongs to the Janus kinase (JAK) family and plays an important role in the pathogenesis of inflammation. According to reports, ICP-332 is about 400 times more selective for JAK2, which can reduce the adverse effects of anemia caused by JAK2 inhibition.
Research results showed that ICP-332 showed better efficacy and safety, and reached multiple efficacy endpoints, including EASI (Eczema Area and Severity Index) percentage change over baseline, EASI 50, EASI 75, EASI 90 (EASI score improved ≥ 50%, 75%, 90% from baseline), investigator overall assessment (IGA) 0/1 (i.e. complete removal or basic removal of skin damage) and an improvement of at least 2 points from baseline, and changes in pruritus NRS score compared to baseline. The percentage change in EASI scores for the 80 mg and 120 mg treatment groups compared to baseline was 78.2% and 72.5%, respectively, with significant statistical differences compared to 16.7% in the placebo group; the EASI 75 response rate for both treatment groups was 64.0%, an improvement of 56.0% compared to the placebo group (8.0%), which was superior to the efficacy of 12 or 16 weeks of monotherapy with various approved innovative drugs.
At the same time, the response rates of EASI 90 and IGA 0/1 in the ICP-332 80 mg group with an improvement of at least 2 points compared to the baseline were 44.0% and 36.0%, respectively, significantly superior to the placebo group (4.0% and 4.0%), which is of significant statistical significance.
In addition, ICP-332 also demonstrated rapid onset characteristics. On the 2nd day of medication, both treatment groups showed statistically significant improvement in pruritus NRS scores compared to baseline changes, and continued to improve until the end of treatment. As itching improved, the quality of life of the subjects in the two treatment groups improved greatly. From day 7, the DLQI score of the two ICP-332 treatment groups showed statistically significant improvements compared to the placebo group, and continued to improve until the end of treatment.