Mumbai, Sept. 22
GLENMARK has filed to commence the first phase of human trials on its prospective diabetes drug molecule GRC 8200 in the UK.
Phase I of the study is expected to be completed in February 2006. Glenmark has also put in place an aggressive clinical development plan for GRC 8200 to reduce the gap with other competing molecules, also in early clinical trials.
In a release issued here today, the company said that its wholly owned subsidiary in Switzerland, Glenmark Pharmaceuticals S.A has filed for Phase I clinical trials for GRC 8200 with the Medicines and Healthcare Products Regulatory Agency [MHRA] in the UK.
The trials will be conducted by Parexel UK, a clinical research organisation, and it will be conducted using single and multiple oral doses on healthy volunteers. The objective of this study is to assess the safety and bio-availability of GRC 8200 in humans. For further development of the molecule, Glenmark plans to initiate a Proof of Concept (Phase IIA) study in South Africa in January 2006 on diabetic patients, along side with the Phase I trials.
Further, it has commenced various other non-clinical studies and expects to file an Investigational New Drug with the US FDA between April and June 2006 to commence Phase II, the note said.