Glenmark Pharmaceuticals Ltd has announced that Glenmark Pharmaceuticals SA. (GPSA), the Swiss subsidiary of the company has completed phase I clinical trials for GRC 6211 in Europe.
GRC 6211 is its lead Vanniloid Receptor (VR1) antagonist compound for a range of pain indications like naturopathic pain, osteoarthritis and urinary incontinence. The company is now initiating a 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, the company plans to initiate a large phase IIB study in the first quarter of CY 2008 for naturopathic pain and osteoarthritis. To ensure the timely start of phase IIB by early 2008, various non-clinical studies are currently ongoing.
The phase I study was conducted on 72 healthy human subjects using single and multiple oral doses with the objectives of assessing safety and pharmacokinetics of 6211. It was found that GRC 6211 was well tolerated by the subjects at all dosages levels and was found to have a good safety profile and predictable pharmacokinetic properties. The highest single ascending dose used for the study was 200 mg. For the multiple dose study three doses (25, 50 and 100 mg) were administered for 12 days.
Glenn Saldanha, managing director and CEO of the company, on this occasion commented, "Glenmark now has three molecules in phase II and expects another three to enter clinical testing over the next six months. Clearly this is a significant achievement for us. Pain management is a large unmet need around the world and GRC 6211 presents an excellent opportunity to capture this large market."
Dr Swaroop Kumar V V S, president - drug discovery and clinical development, Glenmark stated, "The progression of GRC 6211 into phase II is an important scientific achievement for our development programme. The safety profile exhibited by GRC 6211 in phase I human trials is very encouraging. Vanilloid Receptor [VR1] antagonists represent a very important pharmacological intervention to treat several chronic pain conditions."
The company aims to be an early launcher in this class and targets launching the molecule in 2011. The company is in discussions with potential partners for licensing this compound. The timing of licensing would depend on the terms of the deal and the ability to get co-promotion tights for some of the regulated markets. Molecules under development by other companies in the same category include Merck's lead molecule (a molecule in -licensed from Neutrogena and is presently in Phase II), GSK's lead molecule (presently in Phase II) and Pfizer's lead molecule (a molecule in-licensed from Renovis and is presently undergoing pre-clinical trials).