SHANGHAI, Nov. 29, 2024 /PRNewswire/ -- Minghui Pharmaceutical, a late-stage biopharmaceutical company dedicated to developing transformative medicines in immunology and oncology, today announced positive topline results from its phase Ⅲ trial of MH004 (tofacitinib etocomil) ointment 1.0%, a twice-daily pan-Jak inhibitor, in adolescents (ages 12 years and older) and adults with mild to moderate atopic dermatitis (AD).

This multicenter, double-blind, randomized, vehicle-controlled phase Ⅲ clinical trial was conducted to evaluate the efficacy and safety of MH004 1.0% in adolescents and adults with mild to moderate AD. A total of 377 participants were randomized 2:1 to receive either MH004 1.0% or Vehicle BID with an 8-week treatment period, followed by 44-week open-label extension for long-term safety.

The primary endpoints were the proportion of participants achieving IGA-TS (Investigator Global Assessment (IGA) of 'clear' or 'almost clear' with a 2-grade improvement) at Week 4 and the proportion achieving a 75% improvement in Eczema Area and Severity Index (EASI-75) at Week 4. Key efficacy results are as follows:

IGA-TS at Week 4

41.0% of individuals treated with MH004 1.0% achieving IGA-TS at Week 4 compared to 10.3% treated with vehicle (P