Date: 2015-09-03
Type of information: Completion of the trial
phase: 1
Announcement: completion of the trial
Company: Glenmark Pharmaceuticals (India)
Product: GBR 830
Action
mechanism: monoclonal antibody. GBR 830 is a pure antagonist of OX40, a co-stimulatory receptor expressed on T cells mediating T cell activation and survival. OX40 (CD134) is a member of the TNFR/TNF super family and is mainly expressed on activated CD4 and CD8 T cells as well as a number of other lymphoid and non-lymphoid cells. Costimulatory signals from OX40 to an activated T cell promote division and survival, augmenting the clonal expansion of effector and memory populations. OX40 mediated costimulatory signaling plays a central role in the development of multiple inflammatory and autoimmune diseases. Inhibiting these interactions can be used to treat these conditions. Conversely, agents that activate OX40 are being developed to activate T-cells to target cancer cells. No OX40 antagonistic antibodies are currently in clinical stage of development. GBR 830 has been discovered and developed by the Glenmark Biologics Research Centre located in La Chaux-de-Fonds, Switzerland.
Disease: atopic dermatitis
Therapeutic area: Autoimmune diseases - Immunological diseases - Dermatological diseases
Country: The Netherlands
Trial details:
Latest
news: * On September 3, 2015, Glenmark Pharmaceuticals, a wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd., announced that GBR 830, a novel monoclonal antibody has completed clinical phase 1 dosing 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. * On July 3, 2014, Glenmark Pharmaceuticals announced that GBR 830, a novel monoclonal antibody is entering human trials. Glenmark has now completed the Phase I enabling preclinical development program for GBR 830 and has filed a Phase I clinical trial application with The Netherlands authorities. GBR 830 is the first OX40 antagonistic antibody devoid of agonistic properties to enter clinical studies.GBR 830 targets auto-reactive T cells. This cell type drives the pathology in most autoimmune diseases and including, but not limited to illnesses such as rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and lupus. Preclinical head to head comparison with competitor antibodies in animal and translational models of autoimmune disease confirmed the superiority of GBR 830\'s mechanism of action with respect to safety and efficacy and lack of agonism.
