Glenmark Pharmaceuticals Ltd announced yesterday, the positive results in phase-2a clinical trial in terms of safety and efficacy of its molecule, GBR 830 for the treatment of atopic dermatitis.
Atopic dermatitis, also known as eczema, is a chronic skin disease caused by allergic reactions. This disease affects nearly 18 million Americans.
The study evaluated the safety, biological and clinical activity, and pharmacokinetics of GBR 830, relative to a placebo. The trail involved adults with moderate to severe atopic dermatitis with history of inadequate response to topical therapies.
“Atopic dermatitis can have a severe impact on quality of life. 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,” said Fred Grossman, president and chief medical officer of Glenmark.
The phase-2a double‐blind, placebo‐controlled, randomized trial was conducted on 62 patients over 12 weeks. Patients were assessed on multiple endpoints after receiving two doses with two viable biopsies. In the GBR 830 group, 17 out of 23 patients experienced at least a 50% reduction in their Eczema Area and Severity Index (EASI
) scores.Glenn Saldanha, chairman and managing director of the company said, “We have about 6-8 companies interested in GBR 830. This is a transformational product as it could have broad applications beyond atopic dermatitis. Out-licensing deal for this product would be substantial for the company.” Saldanha added Glenmark hopes to close at least one out-licensing deal by the end of this year.
