Minghui Pharmaceutical has reported favorable topline results from its Phase III trial of MH004, a 1.0% tofacitinib etocomil ointment, for treating mild to moderate atopic dermatitis in adolescents and adults. The randomized, vehicle-controlled, double-blind study included 377 participants and evaluated the safety and efficacy of the treatment.
The trial, designed to assess outcomes in individuals aged 12 and older, had participants applying the ointment or a vehicle twice daily for eight weeks. After the treatment phase, a 44-week open-label extension period focused on long-term safety.
Primary endpoints for the study included achieving “clear” or “almost clear” skin with a two-grade improvement and a 75% reduction in the Eczema Area and Severity Index (EASI-75) by week 4. Results showed that 41.0% of subjects using MH004 met the Investigator Global Assessment-Treatment Success (IGA-TS) criteria, compared to just 10.3% in the vehicle group. Additionally, 58.2% of MH004-treated participants achieved EASI-75, compared to 19.8% for the vehicle.
By week 8, the treatment continued to show statistically significant improvements in key secondary endpoints, including IGA-TS, EASI-75, and the Itch Numerical Rating Scale (NRS4). These results highlight MH004’s potential as a fast-acting solution for atopic dermatitis, demonstrating both efficacy and safety.
Minghui’s CEO, Guoqing Cao, commented, “The rapid onset of action observed with MH004 is particularly valuable for patients. These findings reinforce its potential as a meaningful addition to current treatment options for atopic dermatitis, addressing both safety and efficacy needs.” Cao also noted that the therapy could offer benefits for other inflammatory skin diseases, citing promising preliminary data from the company’s ongoing Phase II trial for vitiligo.
The safety profile of MH004 was consistent with previous Phase II study findings, with treatment-related adverse events being mild to moderate in severity. No drug-related serious adverse events were reported.
Earlier this month, Minghui also shared initial results from its Phase I trial of MHB039A, a treatment for relapsed or refractory solid tumors.
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