Comekibart Shows Early Promise for Once-Every-Eight-Weeks Dosing

Recently, Mabgeek Biotech completed a Phase II clinical study evaluating comekibart (MG-K10), administered once every eight weeks, for the treatment of moderate-to-severe atopic dermatitis (AD). The results demonstrate the considerable clinical potential of the MG-K10 once-every-eight-weeks dosing regimen.

This was a multicenter, randomized, double-blind, parallel-controlled Phase II study. A total of 60 patients with moderate-to-severe AD were randomized in a 1:1 ratio to receive either MG-K10 300 mg Q4W, with a 600 mg loading dose, or MG-K10 600 mg Q8W. The primary endpoints were the percentage of participants achieving EASI-75, defined as a ≥75% reduction from baseline in the EASI score, at Week 24, and the percentage of participants achieving an IGA score of 0 or 1 with a ≥2-point improvement from baseline at Week 24. Other efficacy endpoints included EASI-75, EASI-50 and EASI-90 response rates at each study visit, as well as improvements in pruritus NRS scores and quality-of-life scores.

For the primary endpoints, at Week 24, the proportions of participants achieving EASI-75 were 83.3% in the MG-K10 300 mg Q4W group and 88.5% in the MG-K10 600 mg Q8W group. The proportions of participants achieving an IGA score of 0 or 1 with a ≥2-point improvement from baseline were 70.0% and 73.1%, respectively.

For the secondary endpoints, responses continued to improve with increasing treatment duration. The MG-K10 300 mg Q4W and MG-K10 600 mg Q8W groups demonstrated comparable improvements in EASI-75, EASI-50, EASI-90, IGA, DLQI, POEM and weekly NRS scores across study visits, indicating that both MG-K10 dosing regimens provided sustained relief from clinical symptoms and improved quality of life in patients with moderate-to-severe AD.

The safety results showed that both MG-K10 dosing regimens were well tolerated and had favorable safety profiles.

The New Drug Application for MG-K10 in atopic dermatitis, administered at 300 mg Q4W with a 600 mg loading dose, is currently under review in China. This exploratory study of a longer dosing interval provides preliminary yet compelling clinical evidence supporting the potential use of MG-K10 as a once-every-eight-weeks treatment. Mabgeek Biotech will also further develop a once-every-three-months dosing regimen, with the aim of delivering greater benefits to patients.