Novel tyrosine kinase 2 inhibitor looks good for AD

In the treatment of patients with atopic dermatitis, the investigational tyrosine kinase 2 inhibitor ICP-332 demonstrates a favourable safety profile with promising efficacy, according to a phase II study.

The study included 75 adults (72 percent male) who had received a diagnosis of AD for at least 1 year at enrolment and a history of contraindication or inadequate response to topical therapies. These patients were randomly assigned to receive ICP-332 at 80 (n=25) or 120 mg (n=25) or placebo (n=25). Treatment was administered orally once daily for 4 weeks.

Safety was assessed as the primary outcome. The key efficacy outcome was the percentage change from baseline in Eczema Area and Severity Index (EASI) at week 4. Other outcomes were percentages of patients achieving EASI-75 (a ≥75-percent improvement in EASI) and Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) with a ≥2-point improvement.

Patients in the ICP-332 groups were slightly younger than those in the placebo group (mean age, 37.3 vs 44.5 years).

Treatment-emergent adverse events (TEAEs) occurred in 76 percent of patients in the 80-mg ICP-332 group, 75 percent in the 120-mg ICP-332 group, and 68 percent in the placebo group. Decreased blood fibrinogen was the most common TEAE, documented in 44 percent, 21 percent, and 4 percent of patients in the respective groups.

At week 4, EASI decreased by 78.2 percent of patients in the 80-mg ICP-332 group and by 72.5 percent in the 120-mg ICP-332 group vs by 16.7 percent in the placebo group (p<0.001 for both comparisons).

EASI-75 response occurred more frequently with ICP-332 vs placebo (64 percent in each ICP-332 group vs 8 percent in the placebo group; p<0.001). Significantly more patients in the 80-mg ICP-332 group vs the placebo group achieved a Validated Investigator Global Assessment for Atopic Dermatitis score of 0/1 and an improvement of ≥2 points at week 4 (36 percent vs 4 percent; p=0.005).