Shanghai-based Minghui Pharmaceutical, a late-stage biopharmaceutical company specializing in immunology and oncology, has announced positive topline results from its Phase III study for MH004 (tofacitinib etocomil) ointment 1.0%, a twice-daily pan-Jak inhibitor, in adolescents and adults with mild to moderate atopic dermatitis (AD).
Study Design and Participant Enrollment
A total of 377 participants were enrolled in the study, with primary endpoints being the proportion of participants achieving IGA-TS (Investigator Global Assessment 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. The results demonstrated significant efficacy for MH004 1.0%, with 41.0% and 58.2% of individuals treated achieving IGA-TS and EASI-75, respectively, compared to 10.3% and 19.8% treated with the vehicle (P<0.0001).
Secondary Endpoints and Safety Profile
Additionally, key secondary endpoints, including IGA-TS and EASI-75 at Week 8, as well as the proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS4) score at Week 8, were successfully met. MH004 1.0% was well-tolerated, with a safety profile consistent with the previous Phase II study.
MH004 Ointment: A Topical JAK Inhibitor with Proprietary Technologies
MH004 (tofacitinib etocomil) ointment, a topical product containing a JAK inhibitor, was designed and formulated using Minghui’s proprietary technologies. The drug is expected to have much improved skin permeability, achieving extensive target inhibition in local skin tissues without the systemic toxicities associated with oral JAK inhibitors. It is intended for the treatment of multiple dermatologic autoimmune diseases, offering a potential new therapeutic option for patients.-Fineline Info & Tech
