Glenmark Pharmaceuticals S.A., GBR 830, a novel monoclonal antibody has completed clinical phase 1 dosing. GBR 830 is an antagonist of OX40, a costimulatory receptor expressed on T cells mediating T cell activation and survival. Glenmark has now completed clinical phase I studies for GBR 830 in the Netherlands.
Atopic dermatitis (AD) is a chronic, immune-mediated, inflammation of the skin with involvement of activated T cells. Chronic and/or relapsing lesions, associated with itching and scratching are the hallmarks of the disease.
Celiac disease is an autoimmune disease which is triggered by consumption the gluten protein, which is found in wheat, barley and rye. Symptoms include pain and discomfort in the digestive tract, chronic constipation and diarrhoea, anaemia and fatigue.
GBR 830 targets activated T cells. This cell type drives the pathology in most autoimmune diseases including rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease.
GBR 830 was well tolerated and its safety & pharmacokinetics profile in healthy volunteers fully support the transition into clinical phase 2 studies. Preparations for initiating phase 2 studies in both atopic dermatitis and celiac disease in the US and Europe are well advanced. Glenmark expects dosing to commence in the next few months.
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