The primary endpoints of the trial included achieving ‘clear’ or ‘almost clear’ skin with a two-grade improvement at week 4. Credit: Pormezz/Shutterstock.

Minghui Pharmaceutical has reported positive topline outcomes from the randomised Phase III trial of its pan-Jak inhibitor, MH004 (tofacitinib etocomil) ointment 1.0% for treating mild to moderate atopic dermatitis in adolescents and adult populations.

The vehicle-controlled, multicentre, double-blind study is designed to assess the safety and efficacy of the ointment in subjects aged 12 years and older.

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It involved 377 subjects who were randomised to receive either the ointment or vehicle twice a day for eight weeks. Following the initial treatment phase, a 44-week open-label extension assessed the long-term safety.

The primary endpoints included achieving ‘clear’ or ‘almost clear’ skin with a two-grade improvement and a 75% improvement in the Eczema Area and Severity Index (EASI-75) at week 4.

At week 4, 41.0% of subjects treated with the therapy achieved the Investigator Global Assessment-Treatment Success (IGA-TS), versus 10.3% using the vehicle.

Similarly, 58.2% achieved EASI-75, in contrast to 19.8% in the vehicle group.

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Moreover, at week 8, the trial met key secondary endpoints, including IGA-TS and EASI-75, and a significant improvement in the Itch Numerical Rating Scale (NRS4) score at week 8.

Across all these parameters, the treatment demonstrated statistically significant improvements versus the vehicle.

Minghui Pharmaceutical CEO Guoqing Cao said: “The rapid onset of action observed with MH004 is particularly valuable for patients. These findings reinforce MH004’s potential as a meaningful addition to current treatment options for atopic dermatitis, addressing both safety and efficacy needs.

“Moreover, MH004’s benefits may extend to other inflammatory skin diseases as well. In our ongoing Phase II for vitiligo, we have seen convincing PoC, and the preliminary efficacy data looks highly encouraging.”

In terms of safety, the therapy was well-tolerated, with a safety profile consistent with the Phase II study findings.

The treatment-related adverse events were of mild to moderate severity, and no drug-related serious adverse events were reported.

Earlier in the month, the company shared initial outcomes from its Phase I trial of MHB039A, aimed at treating patients with relapsed or refractory solid tumours.