United Lab (03933) announced that its wholly-owned subsidiary, Zhuhai United Laboratories Co., Ltd., has completed a Phase II clinical study for its self-developed Class 1 innovative drug, TUL01101 tablets, in adult patients with moderate-to-severe atopic dermatitis in China.
The study adopted a multicenter, randomized, double-blind, parallel, placebo-controlled design, enrolling 201 subjects who were randomly assigned to three different dose groups of TUL01101 tablets (20mg, 40mg, 60mg) or a placebo group. The treatment lasted 12 weeks with once-daily dosing, aiming to evaluate the efficacy, safety, tolerability, and pharmacokinetic characteristics of TUL01101 tablets in adult patients with moderate-to-severe atopic dermatitis.
The primary efficacy endpoint was the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at Week 12. Key secondary endpoints included the proportion of subjects achieving ≥75% improvement in EASI score from baseline (EASI75 response rate) and the proportion of subjects achieving an Investigator’s Global Assessment (IGA) score of 0/1 with a ≥2-point reduction from baseline (IGA response rate).
Results showed that all TUL01101 dose groups demonstrated significant efficacy, effectively clearing skin lesions, alleviating itching, and improving patients' quality of life. A notable decline in EASI scores was observed as early as Week 1, with all TUL01101 dose groups performing significantly better than the placebo group. Both EASI75 and IGA response rates showed a sustained upward trend during treatment.
At Week 12, the percentage changes in EASI scores from baseline for the 20mg, 40mg, and 60mg groups were -81.98%, -79.87%, and -87.85%, respectively. The EASI75 response rates were 78.0%, 80.0%, and 84.0%, while the IGA response rates were 46.0%, 52.0%, and 68.0%, respectively.
TUL01101 tablets exhibited a favorable overall safety and tolerability profile, with the most common adverse event being upper respiratory tract infections. The majority of adverse events were mild to moderate, with no new safety signals beyond those reported for similar drugs.
The Phase II clinical study of TUL01101 tablets in patients with moderate-to-severe atopic dermatitis met its objectives, supporting progression to the next phase of clinical research. The company has completed End-of-Phase II (EOP2) discussions with regulatory authorities and is preparing to initiate a Phase III clinical trial in China for this indication.
TUL01101 is a highly selective JAK1 inhibitor. To date, it has been approved for clinical trials in China for atopic dermatitis and rheumatoid arthritis. Moving forward, the company plans to expand clinical research on TUL01101 in other autoimmune diseases.
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