United Laboratories' TUL01101 tablets show strong efficacy in atopic dermatitis trial

The Phase II clinical trial for TUL01101 Tablets, a Class 1 new drug, has concluded in China, demonstrating significant efficacy in adult patients with moderate-to-severe atopic dermatitis. The multicenter, randomized, double-blind, parallel, placebo-controlled trial enrolled 201 subjects who received TUL01101 Tablets in three dose groups (20 mg, 40 mg, and 60 mg) or placebo once daily for 12 weeks.

Trial results indicated that all TUL01101 Tablets dose groups significantly reduced Eczema Area and Severity Index (EASI) scores from baseline, with reductions of -81.98% for the 20 mg group, -79.87% for the 40 mg group, and -87.85% for the 60 mg group at Week 12. EASI-75 response rates at Week 12 were 78.0%, 80.0%, and 84.0% respectively, while Investigator's Global Assessment (IGA) response rates were 46.0%, 52.0%, and 68.0% respectively.

The drug exhibited a positive safety and tolerability profile, with the most common adverse event being upper respiratory tract infection, generally mild to moderate in severity. Following these positive results, United Laboratories is now initiating a Phase III clinical trial for TUL01101 Tablets in China.