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

• 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

HANGZHOU, China and SHANGHAI and WILMINGTON, Del. , April 14, 2023 /PRNewswire/ -- 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."

About MH004 Cream

MH004 Cream is a topical cream containing a JAK inhibitor that was designed and formulated with Minghui's proprietary technologies. MH004 Cream is expected to have much improved skin permeability to achieve extensive target inhibition in local skin tissues without systemic toxicities that have been widely reported for oral JAK inhibitors. MH004 Cream is intended to be used for treatment of multiple dermatologic autoimmune diseases including atopic dermatitis.

About Atopic Dermatitis

Atopic dermatitis (AD) is a chronic recurrent inflammatory cutaneous disorder that affects about 20% of children^[1],[2]and up to 10% of adults^[3],[4],[5] in developed countries. The pathogenesis is complex, involving genetic susceptibility, impaired skin barrier function, dysregulation of immunity, and environmental factors^[6],[7]. AD is also associated with sleep disruption, decreased work productivity, and depression, all of which place an additional health and financial burden on patients and their families^[8].

About Minghui Pharmaceutical

Minghui Pharmaceutical Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for unmet medical needs in oncology and autoimmune diseases. Leveraging the expertise in medical science and the proprietary technology platforms, the company is developing a rich clinical-stage pipeline including a variety of first-in-class or best-in-class product candidates. The company's lead product candidate, MH004 Cream, has the potential to become the best-in-class topical treatment for mild-to-moderate atopic dermatitis and other dermatological disorders. For more information, visit www.minghuipharma.com.

Forward-Looking Statements

This press release provided by Minghui Pharmaceutical Inc. (the "Company") contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "predict," "should," "will," "would" or words of similar meaning. These statements are based on the Company's current beliefs and expectations and subject to risks and uncertainties that may cause actual results to differ materially from those set forth in the statements herein. Risks and uncertainties include but not limited to: general industry conditions and competition; changes in economic and financial conditions of the Company's and the collaborators' businesses; the risk that clinical trials are discontinued or delayed for any reasons, including for efficacy, safety, enrollment, or manufacturing; the risk that success in early stage clinical trials may not be predictive of results in later stage trials or trials of other potential indications; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials; expectations for regulatory approvals; challenges to obtain, maintain and enforce patents and other intellectual property protection for the Company's product(s) and product candidate(s). These forward-looking statements speak only as of the date they are posted to this website, and the Company undertakes no obligation to update any forward-looking statements contained herein.

Reference:

[1]. Laughter MR, Maymone MBC, Mashayekhi S, et al. The global burden of atopic dermatitis: lessons from the Global Burden of Disease Study 1990-2017. Br J Dermatol. 2021 Feb;184(2):304-309
[2]. Fuertes E, Flohr C, Silverberg JI, Standl M, Strachan DP; ISAAC Phase Three Study Group. Global Associations between UVR Exposure and Current Eczema Prevalence in Children from ISAAC Phase Three. J Invest Dermatol. 2017 Jun;137(6):1248-1256
[3]. Abuabara K, Yu AM, Okhovat JP, et al. The prevalence of atopic dermatitis beyond childhood: A systematic review and meta-analysis of longitudinal studies. Allergy. 2018 Mar;73(3):696-704
[4]. Lee HH, Patel KR, Singam V, et al. A systematic review and meta-analysis of the prevalence and phenotype of adult-onset atopic dermatitis. J Am Acad Dermatol. 2019 Jun;80(6):1526-1532.e7
[5]. Barbarot S, Auziere S, Gadkari A et al. Epidemiology of atopic dermatitis in adults: results from an international survey. Allergy 2018; 73:1284?93
[6]. Guttman-Yassky E, Waldman A, Ahluwalia J, et al. Atopic dermatitis: pathogenesis. Semin Cutan Med Surg. 2017 Sep;36(3):100-103
[7]. Malik K, Heitmiller KD, Czarnowicki T. An update on the pathophysiology of atopic dermatitis. Dermatol Clin 2017; 35:317?26
[8]. Drucker AM, Wang AR, Li WQ, et al. The Burden of Atopic Dermatitis: Summary of a Report for the National Eczema Association. J Invest Dermatol. 2017 Jan;137(1):26-30

SOURCE Minghui Pharmaceutical, Inc.