Minghui Pharmaceutical, a late-stage biopharma company, said that the MH004 (tofacitinib etocomil) ointment met the primary endpoint in a Phase 3 trial in atopic dermatitis (AD).
This 1.0% ointment is a twice-daily pan-Jak inhibitor. The trial focused on adolescents aged 12 years or older and adults with mild to moderate AD.
The multicentre, double-blind, randomised trial evaluated MH004 in a total of 377 participants. They were randomised 2:1 to receive either MH004 1.0% or a vehicle twice daily (BID) for an eight-week treatment period.
Participants then entered a 44-week open-label extension to assess long-term safety.
The primary endpoints of the trial were the proportion of participants achieving Investigator Global Assessment Treatment Success (IGA-TS) (defined as ‘clear’ or ‘almost clear’ with a 2-grade improvement) and a 75% improvement in EASI (Eczema Area and Severity Index, EASI-75) at week four.
The key efficacy results showed that 41% of participants treated with MH004 1.0% achieved IGA-TS at week four, compared to 10.3% in the vehicle group.
Additionally, 58.2% of participants treated with MH004 1.0% achieved EASI-75 at week four, compared to 19.8% in the vehicle group.
Furthermore, the key secondary endpoints, including IGA-TS and EASI-75 at week eight, as well as the proportion of participants with a ≥ 4-point improvement in the Itch Numerical Rating Scale (NRS4) score at week eight, were successfully met.
MH004 1.0% demonstrated statistically significant improvements across all these parameters compared to the vehicle.
The topical product was well-tolerated, with a safety profile consistent with findings from the previous Phase 2 study.
Minghui Pharmaceutical CEO Guoqing Cao said: “We are thrilled with the positive topline results from the Phase 3 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. 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 2 for vitiligo, we have seen convincing PoC, and the preliminary efficacy data looks highly encouraging.”
Minghui Pharmaceutical is focused on developing new therapies for unmet medical needs in oncology and autoimmune diseases.
Its MH004 is intended for the treatment of multiple dermatologic autoimmune diseases.
Earlier this month, the biopharmaceutical company announced initial results from its Phase 1 clinical trial of MHB039A, a PD-1 x VEGF bispecific antibody, in patients with relapsed/refractory solid tumours.
