Glenmark Pharmaceuticals SA, the Switzerland-based subsidiary of Glenmark Pharmaceuticals, has completed pre-clinical development for initiating phase-I trails of GBR 500, a monoclonal antibody for inflammation.The company intends to file Investigational New Drug (IND) application with US Food and Drug Administration by August for initiation of phase-I trials. It expects to complete phase-I trials in this financial year, followed by a proof of concept Phase-IIa study. The company has already manufactured sufficient antibody for conducting Phase-I and Phase-IIa clinical studies, Glenmark said in a statement to the BSE. "We are happy to take our biologics programme forward with GBR 500 moving into phase-I trials. This is Glenmark's first new biological entities (NBE) to enter the clinics from our pipeline of 11 new chemical entity (NCE) and NBEs, and demonstrates our steady progress in the drug discovery space," Glenmark Pharmaceuticals MD and CEO Glenn Saldanha said. Glenmark intends to develop GBR 500 for treatment of diseases like multiple sclerosis, Chronic Obstructive Pulmonary Disease and Inflammatory Bowel Disease.
