Minghui Pharmaceutical Announces Positive Topline Results from Phase Ⅲ Trial of MH004 (Tofacitinib Etocomil) Ointment in Mild to Moderate Atopic Dermatitis

SHANGHAI, Nov. 29, 2024 /PRNewswire/ -- Minghui Pharmaceutical, a late-stage biopharmaceutical company dedicated to developing transformative medicines in immunology and oncology, today announced positive topline results from its phase Ⅲ trial of MH004 (tofacitinib etocomil) ointment 1.0%, a twice-daily pan-Jak inhibitor, in adolescents (ages 12 years and older) and adults with mild to moderate atopic dermatitis (AD).

This multicenter, double-blind, randomized, vehicle-controlled phase Ⅲ clinical trial was conducted to evaluate the efficacy and safety of MH004 1.0% in adolescents and adults with mild to moderate AD. A total of 377 participants were randomized 2:1 to receive either MH004 1.0% or Vehicle BID with an 8-week treatment period, followed by 44-week open-label extension for long-term safety.

The primary endpoints were the proportion of participants achieving IGA-TS (Investigator Global Assessment (IGA) 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. Key efficacy results are as follows:

• IGA-TS at Week 4
  41.0% of individuals treated with MH004 1.0% achieving IGA-TS at Week 4 compared to 10.3% treated with vehicle (P<0.0001).

• EASI-75 at Week 4
  58.2% of individuals treated with MH004 1.0% achieving EASI-75 at Week 4 compared to 19.8% treated with vehicle (P<0.0001).

Additionally, the 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% demonstrated statistically significant improvements across all these parameters compared to the vehicle.

MH004 1.0% was well-tolerated, with a safety profile consistent with findings from the previous Phase II study. All TRAEs were mild to moderate (grade 1 or 2) in severity. No drug-related serious adverse events (SAEs) were reported.

"We are thrilled with the positive topline results from the Phase Ⅲ study. MH004 showed significant symptom improvement in patients with atopic dermatitis and was well-tolerated." said Guoqing Cao, Ph.D., Chief Executive Officer of Minghui Pharmaceutical. "The rapid onset of action observed with MH004 is particularly valuable for patients. These findings reinforce MH004's potential as a meaningful addition to current treatment options for atopic dermatitis, addressing both safety and efficacy needs. Moreover, MH004's benefits may extend to other inflammatory skin diseases as well. In our ongoing phase Ⅱ for vitiligo, we have seen convincing PoC, and the preliminary efficacy data looks highly encouraging."

Dr. Cao continued, "I would like to extend my sincere gratitude to all the patients who participated in the trial, as well as to the physicians and staff for their dedicated work. Their contributions were essential to the success of this trial. We look forward to working with regulators to make this treatment available to patients as soon as possible."

"Atopic dermatitis is a chronic inflammatory condition, particularly prevalent in children, underscoring the urgent need for effective, fast-acting topical therapies beyond corticosteroids." said Jianzhong Zhang, M.D., lead investigator in the Phase 3 trial and Professor of Peking University People's Hospital. "While corticosteroids are reasonably effective, their long-term use is often limited due to local side effects and safety concerns. MH004 demonstrated superior clinical efficacy in this pivotal phase Ⅲ study, achieving the co-primary endpoints of IGA-TS and EASI-75. The treatment also exhibited a favorable safety profile, and as the leading PI of this study, I am highly encouraged by these results and optimistic about MH004's potential to advance AD care."

About Minghui Pharmaceutical

Minghui Pharmaceutical, established in 2018, is a late-stage biopharmaceutical company committed to developing innovative therapies for unmet medical needs in oncology and autoimmune diseases. Leveraging expertise in medical science and proprietary technology platforms, the company is advancing a robust clinical-stage pipeline that features a range of first-in-class or best-in-class product candidates. For more information, please visit www.minghuipharma.com.

About MH004 Ointment

MH004 (tofacitinib etocomil) ointment is a topical product containing a JAK inhibitor that was designed and formulated with Minghui's proprietary technologies. MH004 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 is intended to be used for the treatment of multiple dermatologic autoimmune diseases.

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.

SOURCE Minghui Pharmaceutical, Inc.