China-based Minghui Pharmaceutical has unveiled positive top-line data from a Phase II trial of its MH004 cream, which is being evaluated as a treatment for adolescents and adults with mild-to-moderate atopic dermatitis (AD). The cream, a pan-JAK inhibitor, successfully met its primary endpoint and all key secondary endpoints, demonstrating its potential efficacy in treating AD.
Phase II Trial Results
The Phase II multi-center, double-blind proof of concept study involved 150 adolescents and adults with AD affecting 3%-20% of body surface area. The trial assessed the performance of MH004 cream against a control group. After 4 weeks of treatment, the 1.0% MH004 cream showed a mean percentage change in EASI score of -78.7% compared to -46.7% in the control group (p = 0.0003). The EASI-75 response, indicating a significant improvement in skin symptoms, was 79.6% for MH004 cream versus 42.0% for the control (p＜0.0001). Additionally, the IGA-TS response, which measures the Investigator’s Global Assessment score, was 46.9% for MH004 cream compared to 20.0% for the vehicle (p = 0.0011).
FDA Approval for Phase III Trials
Building on the positive Phase II data, Minghui Pharmaceutical received approval from the US FDA on April 1, 2023, to begin Phase III clinical trials. These trials will further assess the drug’s efficacy and safety in treating AD, bringing Minghui one step closer to potentially offering a new treatment option for patients suffering from this condition.-Fineline Info & Tech
