The Minghui Pharmaceutical study met both primary and all key secondary endpoints.
Chinese biotech company, Minghui Pharmaceutical, has announced positive topline results from its Phase 2 study evaluating the safety and efficacy of MH004 Cream for the treatment of adolescents and adults with mild-to-moderate atopic dermatitis (AD).1
MH004, a topical cream of a pan-Janus Kinase (JAK) inhibitor, met its primary endpoint in a mid-stage trial of 150 adolescents and adults with mild-to-moderate (AD) covering between 3% and 20% of their body. Participants receiving twice daily topical applications of 1.0% MH004 cream for 4 weeks saw a mean 78.7% change from a baseline on the Eczema Area and Severity Index (EASI) score, compared to 46.7% for individuals who received a placebo cream.
On a secondary efficacy endpoint, 46.9% of individuals treated with 1.0% MH004 showed a response on the IGA-TS measure, which assesses the degree of skin clearing, compared with 20% of those treated with placebo. The trial also included patients who received a 0.3% formulation of the cream, although the company didn't share specific results from this cohort.
The cream was well tolerated, and the rate of treatment-related adverse events was similar between the MH004 and placebo cohorts, according to a press release. There were no serious adverse events reported in the trial.
The topical cream is designed to improve the penetration of low protein binding molecules into multiple skin layers. The goal is to deliver a higher free drug concentration while reducing the rest of the body’s exposure to toxicities associated with believes MH004 could bring particular benefits to dermatological diseases where the skin barrier remains intact, such as alopecia areata, vitiligo and prurigo nodularis.
Minghui CEO Guoqing Cao, Ph.D., stated, “Based on the current phase 2 results, we plan to further pursue the development of MH004 cream in atopic dermatitis as well as other dermatological diseases.”
If successful in phase 3, MH004 would go up against ruxolitinib (Oprezela, Incyte). That is currently the only FDA-approved JAK inhibitor cream, approved for atopic dermatitis and nonsegmental vitiligo.
1. Minghui Pharmaceutical Inc. Announces Phase 2 Clinical Trial Success of MH004 Cream as a Potential Best-in-Class Topical Treatment for Mild-to-Moderate Atopic Dermatitis and the FDA Clearance of its Global Phase 3 MRCT. asiaonecom. Published April 14, 2023. Accessed April 14, 2023. https://www.asiaone.com/business/minghui-pharmaceutical-inc-announces-phase-2-clinical-trial-success-mh004-cream-potential.