Advertisement Clinical Phase I dosing of Glenmark Pharmaceuticals’ GNR 830 completed in Netherlands - Pharmaceutical Business review
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Clinical Phase I dosing of Glenmark Pharmaceuticals’ GNR 830 completed in Netherlands

Glenmark Pharmaceuticals, a wholly owned Swiss subsidiary of Glenmark Pharmaceuticals, has completed the clinical Phase 1 dosing of its GBR 830, a monoclonal antibody, in the Netherlands.

GBR 830 is an antagonist of OX40, a costimulatory receptor expressed on T cells mediating T cell activation and survival.

GBR 830 was found to be well tolerated and its safety and pharmacokinetics profile in healthy volunteers has supported 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.

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

Commenting on the progress with GBR 830, Glenmark Pharmaceuticals chairman & managing director Glenn Saldanha 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.

"The progress of this novel monoclonal antibody into Phase 2 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."