Following in the footsteps of Incyte’s Opzelura, Minghui Pharmaceutical has reported phase 2 results from its own JAK inhibitor that suggests the Chinese biotech’s cream could also be effective against dermatitis.
MH004, a topical cream of a pan-JAK inhibitor, met its primary endpoint in a mid-stage trial of 150 adolescents and adults with mild-to-moderate atopic dermatitis (AD) covering between 3% and 20% of their body. Participants receiving twice daily topical applications of 1.0% MH004 cream for four weeks saw a mean 78.7% change from a baseline on the Eczema Area and Severity Index (EASI) score, compared to 46.7% for individuals who received a placebo cream, according to an April 14 press release.
On a secondary efficacy endpoint, 46.9% of individuals treated with 1.0% MH004 showed a response on the IGA-TS measure, which assesses the degree of skin clearing, compared with 20% of those treated with placebo. The trial also included patients who received a 0.3% formulation of the cream, although the company didn’t share specific results from this cohort.
The cream was well tolerated, and the rate of treatment-related adverse events was similar between the MH004 and placebo cohorts, according to the release. No serious adverse events were reported in the trial, but there was one discontinuation due to an adverse event in the MH004 cohort compared to five in the placebo cohort. Of subjects on the 1.0% formulation, 98% completed the full study.
The topical cream, which is Minghui’s lead asset, is designed to improve the penetration of low protein binding molecules into multiple skin layers. The goal is to deliver a higher free drug concentration while reducing the rest of the body’s exposure to toxicities associated with these drugs—a problem associated with oral JAK inihibitors. The company believes MH004 could bring particular benefits to dermatological diseases where the skin barrier remains intact, such as alopecia areata, vitiligo and prurigo nodularis.
“We observed excellent clinical efficacy with reduced side effects and hence the best-in-class potential,” Minghui CEO Guoqing Cao, Ph.D., said in the release. “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.”
With the FDA already signing off on April 1 on a phase 3 trial, Cao added that the company was looking forward to launching late-stage studies “and the collaboration with any potential partners.”
If successful in phase 3, MH004 would go up against Incyte’s Opzelura, the only FDA-approved JAK inhibitor cream, which is approved for atopic dermatitis and nonsegmental vitiligo. There is also other potential competition on the horizon in the form of Leo Pharma’s delgocitinib, which scored a phase 3 win in chronic hand eczema in February.