Glenmark’s novel monoclonal antibody GBR 830 to enter phase II clinical studies

GBR 830 targets activated T cells, which drives the pathology in most autoimmune diseases including rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease

Glenmark Pharmaceuticals’ GBR 830, a novel monoclonal antibody has completed clinical phase I 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. GBR 830 was well tolerated and its safety and pharmacokinetics profile in healthy volunteers fully support the transition into clinical phase II studies. Preparations for initiating phase II 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. These are indications with an unmet medical need and in addition also offer the possibility to characterise the mode of action of GBR 830 in detail in these patient populations.

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.
Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals said, “We are excited about the progress of GBR 830, the first OX40 Antagonist globally to successfully complete phase I studies. OX40 is a very well validated target with the potential to treat a wide array of autoimmune diseases. However, discovering antibodies that inhibit OX40 and do not have agonistic properties which would lead to unwanted side effects has been challenging for the industry. Based on our data GBR 830 is the best in class OX40 antagonistic antibody.
The progress of this novel monoclonal antibody into phase II for atopic dermatitis and celiac disease indications in the US and Europe reaffirms Glenmark’s capabilities in the area of novel monoclonal antibodies and also the cutting edge work done at our Biologics Research Centre in Switzerland. There is a significant unmet medical need for both indications and we will expeditiously develop this molecule for patients.”