• Study met both primary and all key secondary endpoints
• Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score was -78.7% in 1.0% MH004 Cream-treated group compared to -46.7% in vehicle group
• 79.6% individuals treated with 1.0% MH004 Cream achieved EASI-75 compared to 42.0% of individuals treated with vehicle
• 46.9% individuals treated with 1.0% MH004 Cream achieved Investigator Global Assessment Treatment Success (IGA-TS) compared to 20.0% of individuals treated with vehicle
• MH004 Cream demonstrated a favorable safety and tolerability profile
• IND application for Phase 3 MRCT is approved by FDA

Minghui Pharmaceutical, Inc., a privately held clinical-stage biopharmaceutical company focused on discovering and developing innovative medicines that address significant unmet medical needs in cancer and autoimmune diseases, today announced positive top line results from its Phase 2 study evaluating MH004 Cream, the topical cream of a pan-JAK inhibitor, for treatment of adolescents and adults with mild-to-moderate atopic dermatitis (AD). The study met its primary endpoint of mean percentage changes from baseline in EASI score and all key secondary endpoints including IGA-TS (IGA 0 or 1 with an improvement of ≥2 points from baseline) and EASI-75 response.

The study was a Phase 2 multi-center, double blind, vehicle-controlled proof-of-concept study, in which 150 adolescents (ages 12 years and above) and adults with mild-to-moderate AD involving 3% ~ 20% body surface area (BSA) at baseline were randomized to receive twice daily topical applications of vehicle, 0.3% or 1.0% MH004 Cream for 4 weeks. The study assessed safety, tolerability, pharmacokinetics (PK) and efficacy of two strengths of MH004 Cream.

The study achieved high statistical significance for all the primary and the secondary end points evaluated. The mean percentage changes in EASI score after 4 week treatment of 1.0% MH004 Cream was -78.7% vs vehicle of -46.7% (p = 0.0003), and the efficacy measured by EASI-75 response was 79.6% versus vehicle 42.0% (p＜0.0001), and IGA-TS response 46.9% versus vehicle 20.0% (p = 0.0011).

MH004 Cream was well-tolerated. 98% of subjects on 1.0% MH004 Cream treatment completed the full study. The incidence of treatment-related Treatment Emergent Adverse Events (TEAEs) was similar between the active treatment and the vehicle groups. All the TEAEs were Grade 1 or 2. No Serious Adverse Events (SAEs) were reported in all groups, with only one discontinuation due to a TEAE in 1.0% MH004 Cream group compared to five in vehicle.

"We are very excited about the results from this proof-of-concept study," said Guoqing Cao, Ph.D., Chief Executive Officer at Minghui Pharmaceutical. "MH004 Cream is a topical cream containing a JAK inhibitor that was designed with Minghui's proprietary technology and formulation. These unique designs significantly improved the penetration of low protein binding molecules into multiple skin layers, resulting in a much higher free drug concentration in local skin tissues and much reduced systemic exposure. We observed excellent clinical efficacy with reduced side effects and hence the best-in-class potential. 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."

On April 1, the company received FDA IND approval for AD Phase 3 MRCTs after successful FDA communication and IND submission. "We are very excited about the progress we have made and the FDA clearance of Phase 3 MRCTs. We look forward to initiating Phase 3 studies and the collaboration with any potential partners," said Dr. Guoqing Cao. 

"The Phase 2 result is very impressive. MH004 Cream is a revolutionary product that represents an exciting advancement in topical therapies." said Dr. Kim Papp, a member of the College of Physicians and Surgeons of Ontario, a fellow of the Royal College of Physicians and Surgeons of Canada, and a fellow of the American Academy of Dermatology. "Because of its unique pharmacological properties, it may be more effective in treating dermatological diseases that have intact skin barrier, such as alopecia areata, vitiligo and prurigo nodularis."