The phase I study, the initial introduction of an investigational new drug into humans, was conducted on 72 healthy persons using single and multiple oral doses to study safety of GRC 6211.
The compound was well tolerated by the persons at all dosage levels and was found to have a good safety profile and predictable pharmacokinetic properties.
Glenmark is now initiating Phase IIA proof of concept study for dental pain in Europe and hopes to complete this study by December 2007.
On completion of the dental pain study, Glenmark plans to initiate a large Phase IIB study in the first quarter of 2008 for neuropathic pain and osteoarthritis. To ensure the timely start of Phase IIB by early 2008, various non-clinical studies are currently ongoing, said the company.
Reacting to the development, Glenmark's share prices went up by 0.24 per cent in the Bombay Stock Exchange (BSE) on Monday, up from the previous close of Rs 698.75 to Rs 700.45.
Molecules under development by other companies in the same category include Merck's lead molecule (a molecule in-licensed from Neurogen and is presently in Phase II), GSK's lead molecule (presently in Phase II) and Pfizer's lead molecule in-licensed from Renovis, and is presently undergoing pre-clinical
trials.
Glenmark hopes to launch its drug by 2011 and is in talks with multinational pharmaceutical companies to outlicense the molecule for further development.
Glenmark now has six novel chemical entities at various stages of development. Its first lead Oglemilast for asthma and allergy, was licensed out to Forest Laboratories and Teijin Pharma for the North American and Japanese markets. Oglemilast is presently undergoing Phase II clinical trials in the US.
The company's second lead GRC 8200 for diabetes was recently out-licensed to Merck KGaA. Glenmark has three other programmes on obesity, inflammation and pain management at the pre-clinical stages and plans are to make these leads enter the clinical trial stage during next year.
