#Shanghai #Minghui Pharmaceutical #MH004 #Atopic Dermatitis

Minghui Pharmaceutical's Phase Ⅲ Trial of MH004

Minghui Pharmaceutical, a biopharmaceutical company focused on innovative treatments in immunology and oncology, has released encouraging results from the Phase Ⅲ trial of its product, MH004 (tofacitinib etocomil) ointment. This new topical treatment aims to provide relief for patients suffering from mild to moderate atopic dermatitis (AD).

The clinical trial was designed as a multicenter, double-blind, randomized, vehicle-controlled study. It included 377 participants aged 12 years and older, randomly assigned to receive either MH004 or a placebo vehicle twice daily. The trial consisted of an 8-week treatment phase, followed by a 44-week open-label extension period intended to assess long-term safety.

The findings reveal that MH004 demonstrated superior efficacy compared to the vehicle control. At week 4, 41.0% of participants treated with MH004 achieved the Investigator Global Assessment (IGA) of 'clear' or 'almost clear', a significant improvement over the 10.3% for the vehicle group (P<0.0001). Furthermore, 58.2% of participants on MH004 reached a 75% improvement in the Eczema Area and Severity Index (EASI-75) at week 4, compared to just 19.8% in the control group (P<0.0001).

Secondary endpoints also showed positive results, achieving statistically significant improvements at weeks 4 and 8 for both the IGA-TS and EASI-75 metrics. Additionally, participants demonstrated a marked reduction in itchiness, with many reporting a notable decrease in their Itch Numerical Rating Scale (NRS) scores.

Importantly, the tolerability profile of MH004 was consistent with previous studies. Most reported treatment-related adverse events (TRAEs) were mild to moderate in nature, with no serious drug-related events noted.

Guoqing Cao, Ph.D., CEO of Minghui Pharmaceutical, expressed excitement over the study's outcome, stating, _"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. The rapid onset of action observed with MH004 is particularly valuable for patients."_

Dr. Jianzhong Zhang, the lead investigator, emphasized the importance of such advancements in atopic dermatitis treatment. _"Atopic dermatitis is a chronic condition requiring effective therapies that can work quickly. The favorable results observed with MH004 not only meet clinical efficacy standards but also offer a promising alternative to traditional corticosteroid treatments, which can have limited long-term use due to side effects.