Glenmark Pharmaceuticals initiates phase II study of GBR 500 for Ulcerative Colitis

Glenmark Pharmaceuticals, a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd (GPL) announced that GBR 500 has entered phase II clinical development. This phase II clinical trial is part of a strategic global collaboration between Glenmark and Sanofi to investigate GBR 500 for the treatment of chronic inflammatory disorders.

The study is a randomised, double-blind, placebo-controlled, multi-centre study designed to investigate the efficacy and safety of GBR 500 in patients with moderate to severe ulcerative colitis (UC). The trial will be conducted at multiple clinical sites in North America and Europe, and is expected to include approximately 84 patients. Individuals participating in the study will receive multiple doses of either GBR 500 or placebo, administered over a period of several weeks.

“Despite treatment advances in recent years, UC remains a debilitating condition for many individuals, and represents an area of substantial unmet medical need. We are pleased with the continued progress of our partnership with Sanofi and excited about the commencement of this trial,” said Dr Michael Buschle, Chief Scientific Officer, Glenmark Pharmaceuticals.”

GBR 500 is an antagonist of the VLA2 (alpha2-beta1) integrin. It is a first-in-class therapeutic monoclonal antibody for chronic autoimmune disorders. Glenmark has completed phase I of GBR 500 in the US. Sanofi has licensed the rights to all therapeutic indications and is conducting the clinical development program including this trial.

EP News Bureau