UNITED LAB (03933): The Phase II clinical study of TUL01101 in adult subjects with moderate to severe atopic dermatitis has been completed.

UNITED LAB (03933) announced that its wholly-owned subsidiary, Zhuhai UNITED LAB Co., Ltd., has completed Phase II clinical trials of the innovative drug TUL01101 tablet developed independently in China for adults with moderate to severe atopic dermatitis. The study employed a multicenter, randomized, double-blind, parallel, placebo-controlled design, enrolling a total of 201 subjects who were randomly assigned to three different dose groups of TUL01101 tablets (20mg, 40mg, 60mg) and a placebo group. The subjects received daily dosages for 12 weeks, aiming to evaluate the efficacy, safety, tolerability, and pharmacokinetic characteristics of TUL01101 tablets in adults with moderate to severe atopic dermatitis. The primary efficacy endpoint of the study was the change rate of the Eczema Area and Severity Index (EASI) score from baseline to week 12, with key secondary efficacy endpoints including the proportion of subjects with an improvement of 75% in EASI score at different time points (EASI75 response rate) and the proportion of subjects achieving an Investigator Global Assessment (IGA) score of 0/1 and a reduction of 2 points from baseline. The results of the trial showed that TUL01101 tablets in each dose group were significantly effective in clearing skin lesions, relieving itching, and improving the quality of life of the subjects. A significant decrease in EASI score was observed as early as the first week of treatment, and all dose groups of TUL01101 tablets were significantly superior to the placebo group. The EASI75 and IGA response rates showed a continuous increasing trend during the treatment period. At week 12, the change rates of EASI from baseline for the 20mg, 40mg, and 60mg doses of TUL01101 tablets were -81.98%, -79.87%, and -87.85%, respectively, with EASI75 response rates of 78.0%, 80.0%, and 84.0%, and IGA response rates of 46.0%, 52.0%, and 68.0%, respectively. During the trial, TUL01101 tablets demonstrated good overall safety and tolerability, with the most common adverse event being upper respiratory tract infection, most of which were mild to moderate in severity. No new safety signals were identified outside of the reported class of drugs. The Phase II clinical study of TUL01101 tablets in adults with moderate to severe atopic dermatitis met the expected goals, supporting its progression to the next stage of clinical trials. The company has completed communication with regulatory agencies regarding the EOP2 (End of Phase II clinical trial/Beginning of Phase III clinical trial) of TUL01101 tablets and is initiating Phase III clinical trials in adults with moderate to severe atopic dermatitis in China. TUL01101 tablets are a highly selective JAK1 inhibitor. As of now, clinical trials for atopic dermatitis and rheumatoid arthritis indications have been approved in China. In the future, the company will continue to expand clinical research on TUL01101 in the field of autoimmune diseases.