Glenmark Pharmaceuticals Reports Positive Phase 2a Data for GBR 830 for Atopic Dermatitis

Glenmark Pharmaceuticals shared positive data from a Phase 2a study of GBR 830, an investigational, anti-OX40 monoclonal antibody, for the treatment of atopic dermatitis (AD). The study evaluated the safety, biological and clinical activity, and pharmacokinetics of GBR 830, relative to placebo, in adults with moderate to severe AD with history of inadequate response to topical therapies. Based on the results of this Phase 2a study, Glenmark says it is firmly committed to advancing GBR 830 for patients with AD and plans to initiate a Phase 2b trial in the first half of calendar year 2018.

In this Phase 2a study, a total of 31 patients were evaluated following the last study visit. Patients were assessed on multiple endpoints after receiving two doses with two viable biopsies. In the GBR 830 cohort, 17 out of 23 patients experienced at least a 50 percent reduction in their Eczema Area and Severity Index (EASI) scores at day 57 compared to baseline, a key secondary endpoint of the study. Although not powered for statistical differences between GBR 830 versus placebo, data from this analysis suggest clinically meaningful improvement of symptoms that is continuous and sustained, with consistency observed between biological and clinical response.

"Atopic dermatitis can have a severe impact on quality of life. There is an unmet need for safe and more durable therapies for people suffering from atopic dermatitis," said Dr. Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals. "GBR 830 is a novel, antagonistic monoclonal antibody that is designed to selectively target OX40 receptors to reduce inflammation in atopic dermatitis. We are pleased with the outcome of our Phase 2a study and look forward to rapidly advancing GBR 830."