Sep 13 2012
Glenmark Pharmaceuticals S.A. (GPSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Limited (GPL), announced today 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.
This study is a randomized, double-blind, placebo-controlled, multi-center 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," said Dr. Michael Buschle, Chief Scientific Officer, Glenmark Pharmaceuticals Ltd. "We're pleased with the continued progress of our partnership with Sanofi and excited about the commencement of this trial."
SOURCE Glenmark Pharmaceuticals Ltd