Minghui Pharmaceutical has announced positive topline results from its Phase III clinical trial evaluating MH004 (tofacitinib etocomil) ointment 1.0% for the treatment of mild to moderate atopic dermatitis (AD) in adolescents and adults. The multi-center, double-blind, randomized, vehicle-controlled study demonstrated statistically significant improvements in primary and key secondary endpoints, suggesting MH004 could offer a safe and effective topical treatment option for AD patients.
The Phase III trial involved 377 participants aged 12 years and older with mild to moderate AD. Subjects were randomized 2:1 to receive either MH004 1.0% or a vehicle control twice daily for eight weeks, followed by a 44-week open-label extension to assess long-term safety. The primary endpoints were the proportion of participants achieving Investigator Global Assessment-Treatment Success (IGA-TS) and a 75% improvement in Eczema Area and Severity Index (EASI-75) at week 4.
Key Efficacy Outcomes
At week 4, 41.0% of subjects treated with MH004 1.0% achieved IGA-TS compared to 10.3% treated with the vehicle (P<0.0001). Similarly, 58.2% of individuals treated with MH004 1.0% achieved EASI-75 at week 4, while only 19.8% of the vehicle group reached this endpoint (P<0.0001). Key secondary endpoints, including IGA-TS and EASI-75 at week 8, and a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS4) score at week 8, were also met with statistical significance.
Safety and Tolerability
MH004 1.0% was reported to be well-tolerated, with a safety profile consistent with previous Phase II study findings. Treatment-related adverse events (TRAEs) were mild to moderate in severity, and no drug-related serious adverse events (SAEs) were reported.
Expert Commentary
"Atopic dermatitis is a chronic inflammatory condition, particularly prevalent in children, underscoring the urgent need for effective, fast-acting topical therapies beyond corticosteroids," said Jianzhong Zhang, M.D., lead investigator in the Phase 3 trial and Professor of Peking University People's Hospital. "While corticosteroids are reasonably effective, their long-term use is often limited due to local side effects and safety concerns. MH004 demonstrated superior clinical efficacy in this pivotal phase III study, achieving the co-primary endpoints of IGA-TS and EASI-75. The treatment also exhibited a favorable safety profile, and as the leading PI of this study, I am highly encouraged by these results and optimistic about MH004's potential to advance AD care."
Future Implications
These positive Phase III results suggest that MH004 (tofacitinib etocomil) ointment 1.0% could become a valuable addition to the treatment landscape for mild to moderate atopic dermatitis. The rapid onset of action and favorable safety profile, as noted by Minghui Pharmaceutical CEO Guoqing Cao, Ph.D., address critical needs in current AD management. Furthermore, ongoing Phase II studies for vitiligo suggest potential applications in other inflammatory skin diseases.
