Glenmark To Ask FDA Approval For Trials

Glenmark hopes to file an investigational new drug (IND) application with the US regulatory authority by August, to begin the first phase of human trials on its monoclonal antibody (GBR 500). The prospective drug molecule, GBR 500, is being developed to aim multiple sclerosis, chronic obstructive pulmonary disease and inflammatory bowel disease. The prospective molecule is Glenmark''s first NBE (new biological entity) to foray clinical studies from the company''s pipeline of 11 NCEs (new chemical entities) and NBEs. Stating that its wholly-owned subsidiary Glenmark Pharmaceuticals SA (Switzerland) had finished pre-clinical studies, the Mumbai-based drug company said that it will seek regulatory approval from the US Food and Drug Administration to start phase I trials on the prospective molecule.