Glenmark Pharmaceuticals, a wholly-owned subsidiary of Glenmark Pharmaceuticals, has commenced the Phase II study of GBR 500 for ulcerative colitis.
GBR 500, an antagonist of the VLA2 (alpha2-beta1) integrin, is a first-in-class therapeutic monoclonal antibody for chronic autoimmune disorders.
The randomised, double-blind, placebo-controlled study will investigate the efficacy and safety of GBR 500 in patients with moderate to severe ulcerative colitis (UC).
Glenmark Pharmaceuticals chief scientific officer Dr Michael Buschle said that UC represents an area of substantial unmet medical need, despite treatment advances in recent years.
"We're pleased with the continued progress of our partnership with Sanofi and excited about the commencement of this trial," Buschle said.
The trial, which will be conducted at multiple clinical sites in North America and Europe, is expected to involve approximately 84 patients.
Patients participating in the study will receive multiple doses of either GBR 500 or placebo, administered over a period of several weeks.
Glenmark has completed Phase I of GBR 500 in the US, won licensing rights to all therapeutic indications from Sanofi and is conducting the clinical development programme.
The trial is part of a strategic global collaboration between Glenmark and Sanofi to investigate GBR 500 for the treatment of chronic inflammatory disorders.
Image: Histopathological image of the active stage of ulcerative colitis. Endoscopic biopsy. Hematoxylin & eosin stain. Photo: Courtesy of KGH.