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Glenmark enters phase II trial for new drug molecule aimed to treat Ulcerative colitis.
But 1st what exactly does this drug do. How does it work? I wanted to find out - Here's some info -GBR 500, a novel monoclonal antibody for the treatment of Crohn's Disease and other inflammatory conditions.
GBR 500 is an antagonist of the VLA-2 (alpha2-beta1) integrin. It is a first-in-class therapeutic monoclonal antibody and has established proof of concept in animal models across a range of anti-inflammatory conditions. Glenmark has completed Phase I dosing of GBR 500 in the US and the drug has been well tolerated with a good pharmacokinetic profile. Plans are in place to initiate clinical proof of concept studies in Crohn's Disease. Sanofi has licensed the rights to all therapeutic indications.
"There continues to be a strong medical need for safer and more efficacious products for the treatment of Inflammatory Diseases," said Elias Zerhouni, M.D., President, Global Research & Development, Sanofi. "GBR500 brings an innovative approach to Sanofi's Immuno-Inflammation portfolio, which we believe may address a significant gap in treating Inflammatory Diseases which would be of huge benefit to patients".
Now on with the article about Glenmark Pharm entering into phase II .......
Glenmark Pharmaceuticals today said that 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, it added.
Commenting on the development, Glenmark Pharmaceuticals Chief Scientific Officer Michael Buschle said: “Despite treatment advances in recent years, ulcerative colitis 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 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 programme 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 their previous close.