The phase II clinical results of Mabgeek Biotech's long-acting anti-IL-4Rα monoclonal antibody MG-K10 were published in Dermatitis.

The phase II clinical trial results of MG-K10, a humanized monoclonal antibody injection targeting IL-4Rα independently developed by Mabgeek Biotech for the treatment of moderate to severe atopic dermatitis in adults, were recently published online in Dermatitis.

This study was a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial, primarily aimed at evaluating the efficacy and safety of different doses of MG-K10 in treating patients with moderate to severe atopic dermatitis (AD). A total of 163 patients with moderate to severe AD were randomly assigned in a 1:1:1:1 ratio to receive 16 weeks of MG-K10 treatment at doses of 150 mg every 4 weeks (150 mg Q4W) (n = 41), 300 mg every 2 weeks (300 mg Q2W) (n = 41), 300 mg every 4 weeks (300 mg Q4W) (n = 41), or placebo (n = 40). The primary endpoint was the percentage change in the Eczema Area and Severity Index (EASI) score from baseline at week 16.

The research results showed that the percentage change in EASI score from baseline at the 16th week of the main endpoint in each dose group of MG-K10 was higher than that in the placebo group. The percentages of improvement in EASI score from baseline in the 150 mg Q4W group, 300 mg Q2W group, 300 mg Q4W group, and the placebo group were -58.72%, -69.77%, -81.55%, and -42.72%, respectively. The 300 mg dose groups were all significantly better than the placebo group, with the differences between the 300 mg Q2W group and the placebo group, and the 300 mg Q4W group and the placebo group being -27.06% (P < 0.003) and -38.83% (P < 0.001), respectively.

In Week 16, the proportions of subjects achieving EASI-75 in the 150mg Q4W group, 300mg Q2W group, 300mg Q4W group and placebo group were 53.8%, 66.7%, 79.5% and 28.9% respectively. The MG-K10 groups at all doses demonstrated higher response rates. Additionally, the percentage of subjects achieving EASI 90 in the 300mg Q4W dose group was 53.8%, while in the placebo group it was 15.8%, with an intergroup difference of 38.0% (P < 0.001).

In terms of the Investigator's Global Assessment (IGA) index, the proportions of subjects in the 150mg Q4W group, 300mg Q2W group, 300mg Q4W group and placebo group who achieved an IGA score of 0/1 (i.e., complete or near-complete clearance of skin lesions) and a decrease of ≥2 points from baseline at Week 16 were 46.2%, 46.2%, 51.3% and 15.8%, respectively. All MG-K10 dose groups were significantly higher than the placebo group, with a difference of 35.5% between the 300mg Q4W group and the placebo group (P < 0.001).

MG-K10 also performed exceptionally well in alleviating patients' pruritus. The change rates of NRS from baseline at week 16 in the 300mg Q2W group, 300mg Q4W group, and placebo group were -54.15%, -60.41%, and -30.38% respectively. The differences between the two treatment groups and the placebo group began to emerge as early as the first week of the treatment period.

The MG-K10 300mg dose group significantly outperformed the placebo group in other efficacy-related indicators such as the body surface area (BSA) affected by atopic dermatitis, the Dermatology Life Quality Index (DLQI), and the Patient-Oriented Eczema Measure (POEM) score.

Overall, MG-K10 takes effect rapidly in adult patients with moderate to severe AD. It can relieve itching within the first week, and its therapeutic effect continues to enhance during subsequent treatment. Moreover, the improved condition can be maintained for 8 weeks after discontinuation of the drug.

Throughout the entire study period, the incidence of adverse events in the MG-K10 dose group was comparable to that in the placebo group. The severity of adverse events related to the study drug was grade 1 or 2. No serious adverse events (SAEs) related to the study drug occurred, no adverse events of special interest (AESIs) were observed, and no common adverse events such as injection site reactions or conjunctivitis related to the drug class were reported.

The results of this study show that adult patients with moderate to severe AD who received MG-K10 treatment demonstrated varying degrees of effective improvement in clinical symptoms and quality of life, with the 300 mg Q4W dose group of MG-K10 showing the best therapeutic effect.

All the marketed drugs targeting the same site are administered every two weeks, requiring 26 injections per year. However, the clinical validation of MG-K10 supports administration every four weeks, reducing the number of injections by half each year. This provides an innovative, highly effective, safe, more economical and better-compliant treatment option for AD patients.

The marketing authorization application for MG-K10 in the treatment of moderate to severe AD in adults has been accepted by the National Medical Products Administration (NMPA) of China. We hope it will benefit more AD patients as soon as possible.