New Delhi: Drug maker Glenmark Pharmaceuticals today said it has entered the phase II clinical trials for its new drug molecule aimed at treating ulcerative colitis.
The company`s subsidiary Glenmark Pharmaceuticals SA will conduct trials at multiple clinical sites in North America and Europe to investigate the efficacy and safety of the new molecule GBR 500, Glenmark Pharmaceuticals said in a statement.
It is expected that the trial will include nearly eighty four patients with moderate to severe ulcerative colitis (UC), it added.
Commenting on the development Glenmark Pharmaceuticals Chief Scientific Officer Michael Buschle said: "Despite treatment advances in recent years, UC remains a debilitating condition for many individuals, and represents an area of substantial unmet medical need."
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 company said.
Sanofi has been licensed the rights to all therapeutic indications and is conducting the clinical development program including this trial, it added.
Individuals participating in the study will receive multiple doses of either GBR 500 or placebo, administered over a period of several weeks, it added.
In the Phase II clinical trials of drug development, a larger group of people (100-300) is given experimental treatment to check the efficacy and safety of the molecule.
The company has completed Phase I trials (done on a smaller set of human subjects) of GBR 500, a monoclonal antibody in the US, Glenmark said.
Shares of Glenmark Pharmaceuticals were today trading at Rs 435 per scrip on BSE, up 0.88 per cent from its previous close.