Glenmark Pharmaceuticals SA, the Swiss subsidiary of Glenmark Pharmaceuticals Ltd, on September 3, 2015 announced that 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.
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. These are indications with an unmet medical need and in addition also offer the possibility to characterize 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.
Commenting on the progress with GBR 830, Glenn Saldanha, chairman & managing director, Glenmark Pharmaceuticals said, “We are excited about the progress of GBR 830, the first OX40 Antagonist globally to successfully complete Phase 1 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.”
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. These are indications with an unmet medical need and in addition also offer the possibility to characterize 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.
Commenting on the progress with GBR 830, Glenn Saldanha, chairman & managing director, Glenmark Pharmaceuticals said, “We are excited about the progress of GBR 830, the first OX40 Antagonist globally to successfully complete Phase 1 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.”
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