|The following article is part of conference coverage from the 2018 Fall Clinical Dermatology Conference in Las Vegas, Nevada.Dermatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in dermatology. Check back for the latest news from Fall Clinical Derm 2018.|
Early efficacy data on monoclonal antibody GBR 830 shows long-term improvements and reductions in biomarkers of atopic dermatitis. These findings were presented at the 2018 Fall Clinical Dermatology Conference, October 18-21, 2018 in Las Vegas, Nevada.
The researchers conducting this investigational phase 2a study evaluated the impact of 2 repeated doses of GBR 830 on changes in the Eczema Area and Severity Index and disease-related biomarkers in patients with moderate to severe atopic dermatitis. Patients were randomly assigned to a treatment arm or a control arm for either the intent-to-treat cohort (N=62) or the biological activity cohort (N=40). All evaluations were completed at baseline, day 29, and day 71.
The patients in the intent-to-treat cohort receiving GBR 830 (n=46) experienced a change of 44% in the Eczema Area and Severity Index by day 29 and a change of 78% by day 71, compared with a change of 23% by day 29 and 38% by day 71 in the patients in the control arm. The patients in the biological activity cohort receiving GBR 830 (n=29) experienced significant improvements in atopic dermatitis biomarker signatures when compared with patients in the control arm from baseline to the evaluation time points. The most common adverse events, headache and atopic dermatitis, were comparable in both the treatment and control arms.
A second presentation at the conference also highlighted the ability of GBR 830 to reduce both inflammation and autoimmune disease severity by suppressing OX40, an immune checkpoint receptor. Based on the early findings of these studies, a phase 2b study, OX40 for Atopic Dermatitis (OXFORAD), was launched in June 2018.
Glenmark Pharmaceuticals’ president and chief medical officer, Mahboob Rahman, stated in a press release that the “[p]resentation of these data from a Phase 2a study of our lead biologic candidate, GBR 830, along with detailed ex vivo studies that elucidate its mechanism, is part of our continued commitment to further analyze and characterize the unique profile and activity of this potential treatment for atopic dermatitis.”
In conclusion, GBR 830 may be an effective and safe long-term treatment option for patients with moderate to severe atopic dermatitis, potentially altering the biological mechanisms behind this autoimmune disease.
For more coverage of Fall Clinical Derm 2018, click here.
Data on Glenmark Pharmaceuticals’ GBR 830, a first-in-class, investigational, anti-OX40 monoclonal antibody in development for the treatment of moderate-to-severe atopic dermatitis, to be presented at the fall clinical dermatology conference [news release]. Mahwah, NJ: Glenmark Pharmaceuticals. Updated October 18, 2018. Accessed October 18, 2018.