The phase I study will be conducted using single and multiple oral doses with the objective of assessing safety and bioavailability of GRC 6211 in healthy human beings. Glenmark would also be conducting, in parallel, a phase IIA study on patients with dental pain. Glenmark hopes to complete phase I by June 2007 and the dental pain study by October 2007.
“Preclinical studies have demonstrated GRC 6211 to be highly potent with functional IC50 of 3.8 nM and good bioavailability across species tested. The molecule also exhibited greater than 2600 selectivity over other TRP channels,” stated Dr Swaroop Kumar president of Drug Discovery & Clinical Development for Glenmark.
Glenmark is also in discussions for potential licensing partners for this compound. The company targets launching the molecule in 2011 and aims to be an early launcher in this class.